Asthma, Healthy Participants
Conditions
Keywords
salbutamol, propellant HFA-152a, propellant HFA-134a, metered dose inhalers, healthy participants, asthma
Brief summary
The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).
Interventions
100 µg (ex-valve), given at 20-second intervals.
100 µg (ex-valve), given at 20-second intervals.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4-way crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal. 2. Age: 18 to 55 years inclusive. 3. Weight: 45 to 110 kg inclusive 4. Status: healthy participants. 5. Females must not be pregnant or lactating. 6. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study. 7. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center. 8. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center. 9. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center. 10. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator. 11. Serum potassium and serum glucose levels within reference ranges of the clinical research center. 12. Willing and able to sign the informed consent form. 13. Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.
Exclusion criteria
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs. 2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma. 3. At screening, systolic blood pressure \<90 mmHg or \>140 mmHg, or diastolic blood pressure \<50 mmHg or \>90 mmHg. 4. History of pathological tachycardia, or a pulse rate \> 85 beats per minute (bpm) at screening or Day-1. 5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 6. Breast cancer within the past 10 years. 7. A QTcF value of \>450 msec at screening based on a triplicate measurement taken at a single timepoint. 8. Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study. 9. Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study. 10. Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study. 11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 12. Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention. 13. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained. 14. Positive pre-study drug/alcohol screen, including tetrahydrocannabinol. 15. Positive HIV antibody test. 16. Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening. Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments. 17. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits. 18. Regular use of known drugs of abuse, including tetrahydrocannabinol. 19. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to vape within 6 months prior to screening. 20. Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.). 21. Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
| Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
| Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
| Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
| Cohort 2: Maximum Observed Plasma Concentration (Cmax) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Intra Participant Variability of Cmax | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)] | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | Blood samples were collected for analyzing absolute values of glucose and potassium |
| Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available. |
| Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available. |
| Cohort 2: Time to Reach Cmax (Tmax) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4] | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Apparent Terminal Phase Half-life (t1/2) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2-Intra-Participant Variability of AUC (0-30min) | At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Intra Participant Variability of AUC (0-infinity) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Intra Participant Variability of AUC (0-last) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Intra Participant Variability of Cmax | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)] | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge) | A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position. |
| Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1) and Day 11 (Discharge) | Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value |
| Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | Blood samples were collected for analyzing absolute values of glucose and potassium |
| Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available. |
| Cohort 1: Time to Reach Cmax (Tmax) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4] | Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available. |
| Cohort 1: Apparent Terminal Phase Half-life (t1/2) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 1-Intra-Participant Variability of AUC (0-30min) | At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 1: Intra Participant Variability of AUC (0-infinity) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
| Cohort 1: Intra Participant Variability of AUC(0-last) | At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4) | Blood samples were collected for the analysis of PK parameters. |
Countries
Netherlands
Participant flow
Pre-assignment details
The study consisted of two cohorts: Cohort 1 (200 µg dose) and Cohort 2 (800 µg dose). Each cohort included two treatment sequences, TRRT and RTTR, where T represents salbutamol delivered using HFA-152a MDI (test) and R represents salbutamol delivered using HFA-134a MDI (reference). Participants were randomized to 1 of the 2 treatment sequences within each cohort.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: TRRT1 Healthy participants in Cohort 1 received TRRT1, where T represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and R represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7 | 16 |
| Cohort 1: RTTR1 Healthy participants in Cohort 1 received RTTR1, where T represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and R represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10 | 14 |
| Cohort 2: TRRT2 Healthy participants in Cohort 2 received TRRT2, where T represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and R represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7 | 14 |
| Cohort 2: RTTR2 Healthy participants in Cohort 2 received RTTR2, where T represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and R represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10 | 16 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Cohort 1 - Treatment Period 3 (Day 7) | Physician Decision | 0 | 1 | 0 | 0 |
| Cohort 1 - Treatment Period 3 (Day 7) | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Cohort 2 - Treatment Period 2 (Day 4) | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: TRRT1 | Total | Cohort 2: RTTR2 | Cohort 2: TRRT2 | Cohort 1: RTTR1 |
|---|---|---|---|---|---|
| Age, Customized 18 to 55 years | 16 Participants | 60 Participants | 16 Participants | 14 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 56 Participants | 16 Participants | 13 Participants | 14 Participants |
| Sex: Female, Male Female | 11 Participants | 33 Participants | 5 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 27 Participants | 11 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 12 / 30 | 7 / 30 | 16 / 30 | 21 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 | 0 / 30 | 0 / 29 |
Outcome results
Primary
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | 5734.92 h*pg/mL |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | 4431.63 h*pg/mL |
90% CI: [1.1795, 1.4199]
Primary
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population included all participants in the Full Analysis Set who had at least 1 non-missing assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | 156.41 Hour * Picogram per Milliliter (h*pg/mL) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | 162.11 Hour * Picogram per Milliliter (h*pg/mL) |
90% CI: [0.8695, 1.0707]
Primary
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Maximum Observed Plasma Concentration (Cmax) | 639.28 Picogram per milliliter (pg/mL) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Maximum Observed Plasma Concentration (Cmax) | 518.51 Picogram per milliliter (pg/mL) |
90% CI: [1.1171, 1.3608]
Primary
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | 17098.45 h*pg/mL |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity]) | 14210.59 h*pg/mL |
90% CI: [1.162, 1.2459]
Primary
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | 443.33 Hour * Picogram per Milliliter (h*pg/mL) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) | 467.88 Hour * Picogram per Milliliter (h*pg/mL) |
90% CI: [0.7746, 1.159]
Primary
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Maximum Observed Plasma Concentration (Cmax) | 1891.30 Picogram per milliliter (pg/mL) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Maximum Observed Plasma Concentration (Cmax) | 1677.79 Picogram per milliliter (pg/mL) |
90% CI: [1.0229, 1.2423]
Secondary
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 1 [Period 1] | 396.4 milliseconds (ms) | Standard Deviation 15.5 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 7 [Period 3] | 403.6 milliseconds (ms) | Standard Deviation 19.66 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 4 [Period 2] | 400.4 milliseconds (ms) | Standard Deviation 19.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 10 [Period 4]) | 397.6 milliseconds (ms) | Standard Deviation 13.14 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 4 [Period 2]) | 411.9 milliseconds (ms) | Standard Deviation 18.94 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 10 [Period 4] | 392.7 milliseconds (ms) | Standard Deviation 13.92 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 7 [Period 3]) | 412.4 milliseconds (ms) | Standard Deviation 18.3 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Day 11(Discharge) | 388.9 milliseconds (ms) | Standard Deviation 14.24 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 1 [Period 1]) | 403.0 milliseconds (ms) | Standard Deviation 16.12 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Day 11(Discharge) | 402.5 milliseconds (ms) | Standard Deviation 19.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 1 [Period 1]) | 411.6 milliseconds (ms) | Standard Deviation 18.7 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 1 [Period 1] | 402.4 milliseconds (ms) | Standard Deviation 16.22 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 4 [Period 2]) | 399.0 milliseconds (ms) | Standard Deviation 15.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 4 [Period 2] | 393.1 milliseconds (ms) | Standard Deviation 16.8 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 7 [Period 3]) | 397.4 milliseconds (ms) | Standard Deviation 13.64 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 7 [Period 3] | 389.9 milliseconds (ms) | Standard Deviation 12.09 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Baseline (Pre-dose at Day 10 [Period 4]) | 411.1 milliseconds (ms) | Standard Deviation 18.06 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals | Post-dose at 30 minutes on Day 10 [Period 4] | 399.8 milliseconds (ms) | Standard Deviation 21.48 |
Secondary
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 1 [Period 1] | 63.1 Beats per minute | Standard Deviation 7.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 7 [Period 3] | 67.9 Beats per minute | Standard Deviation 9.79 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 4 [Period 2] | 62.3 Beats per minute | Standard Deviation 5.98 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 10 [Period 4]) | 56.5 Beats per minute | Standard Deviation 6.88 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 4 [Period 2]) | 53.6 Beats per minute | Standard Deviation 6.32 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 10 [Period 4] | 64.9 Beats per minute | Standard Deviation 9.31 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 7 [Period 3]) | 55.4 Beats per minute | Standard Deviation 7.37 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Day 11 (Discharge) | 60.7 Beats per minute | Standard Deviation 10.59 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 1 [Period 1]) | 55.1 Beats per minute | Standard Deviation 6.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Day 11 (Discharge) | 61.2 Beats per minute | Standard Deviation 8.96 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 1 [Period 1]) | 52.7 Beats per minute | Standard Deviation 5.14 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 1 [Period 1] | 62.6 Beats per minute | Standard Deviation 7.56 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 4 [Period 2]) | 55.0 Beats per minute | Standard Deviation 8.06 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 4 [Period 2] | 62.8 Beats per minute | Standard Deviation 5.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 7 [Period 3]) | 56.6 Beats per minute | Standard Deviation 6.71 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 7 [Period 3] | 62.3 Beats per minute | Standard Deviation 8.68 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 10 [Period 4]) | 53.7 Beats per minute | Standard Deviation 5.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 10 [Period 4] | 64.2 Beats per minute | Standard Deviation 7.83 |
Secondary
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Blood samples were collected for analyzing absolute values of glucose and potassium
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Glucose | 4.63 millimoles per liter (mmol/L) | Standard Deviation 0.307 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Glucose | 4.97 millimoles per liter (mmol/L) | Standard Deviation 0.803 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Glucose | 4.86 millimoles per liter (mmol/L) | Standard Deviation 0.453 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Glucose | 5.20 millimoles per liter (mmol/L) | Standard Deviation 0.716 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Glucose | 4.99 millimoles per liter (mmol/L) | Standard Deviation 0.509 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Glucose | 4.77 millimoles per liter (mmol/L) | Standard Deviation 0.322 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Glucose | 4.50 millimoles per liter (mmol/L) | Standard Deviation 0.31 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Glucose | 4.71 millimoles per liter (mmol/L) | Standard Deviation 0.284 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Glucose | 4.80 millimoles per liter (mmol/L) | Standard Deviation 0.706 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Glucose | 4.70 millimoles per liter (mmol/L) | Standard Deviation 0.553 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Glucose | 4.84 millimoles per liter (mmol/L) | Standard Deviation 0.445 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Glucose | 4.74 millimoles per liter (mmol/L) | Standard Deviation 0.346 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Glucose | 4.71 millimoles per liter (mmol/L) | Standard Deviation 0.196 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Glucose | 4.57 millimoles per liter (mmol/L) | Standard Deviation 0.258 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Glucose | 4.76 millimoles per liter (mmol/L) | Standard Deviation 0.206 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Glucose | 4.66 millimoles per liter (mmol/L) | Standard Deviation 0.852 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Glucose | 4.56 millimoles per liter (mmol/L) | Standard Deviation 0.577 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Glucose | 4.75 millimoles per liter (mmol/L) | Standard Deviation 0.32 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Glucose | 4.76 millimoles per liter (mmol/L) | Standard Deviation 0.414 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Glucose | 4.57 millimoles per liter (mmol/L) | Standard Deviation 0.358 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Glucose | 4.51 millimoles per liter (mmol/L) | Standard Deviation 0.236 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Glucose | 4.62 millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Glucose | 4.97 millimoles per liter (mmol/L) | Standard Deviation 0.701 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Glucose | 4.90 millimoles per liter (mmol/L) | Standard Deviation 0.65 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Glucose | 5.01 millimoles per liter (mmol/L) | Standard Deviation 0.476 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Glucose | 4.60 millimoles per liter (mmol/L) | Standard Deviation 0.28 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Glucose | 4.47 millimoles per liter (mmol/L) | Standard Deviation 0.246 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Glucose | 4.55 millimoles per liter (mmol/L) | Standard Deviation 0.304 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Potassium | 4.19 millimoles per liter (mmol/L) | Standard Deviation 0.208 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Potassium | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.261 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.342 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Potassium | 4.16 millimoles per liter (mmol/L) | Standard Deviation 0.175 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.188 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.219 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.268 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Potassium | 4.33 millimoles per liter (mmol/L) | Standard Deviation 0.367 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Potassium | 4.47 millimoles per liter (mmol/L) | Standard Deviation 0.307 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Potassium | 4.27 millimoles per liter (mmol/L) | Standard Deviation 0.205 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Potassium | 4.27 millimoles per liter (mmol/L) | Standard Deviation 0.194 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.196 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Potassium | 4.19 millimoles per liter (mmol/L) | Standard Deviation 0.188 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.167 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Potassium | 4.41 millimoles per liter (mmol/L) | Standard Deviation 0.337 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Potassium | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.268 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.255 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Potassium | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.125 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.247 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.119 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.239 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Potassium | 4.17 millimoles per liter (mmol/L) | Standard Deviation 0.167 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.327 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Potassium | 4.22 millimoles per liter (mmol/L) | Standard Deviation 0.258 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Potassium | 4.19 millimoles per liter (mmol/L) | Standard Deviation 0.233 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Potassium | 4.15 millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.167 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Potassium | 4.15 millimoles per liter (mmol/L) | Standard Deviation 0.133 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Glucose | 4.89 millimoles per liter (mmol/L) | Standard Deviation 0.363 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Potassium | 4.37 millimoles per liter (mmol/L) | Standard Deviation 0.289 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Glucose | 4.60 millimoles per liter (mmol/L) | Standard Deviation 1.06 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Potassium | 4.35 millimoles per liter (mmol/L) | Standard Deviation 0.228 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Glucose | 4.71 millimoles per liter (mmol/L) | Standard Deviation 0.691 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Potassium | 4.29 millimoles per liter (mmol/L) | Standard Deviation 0.244 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Glucose | 4.92 millimoles per liter (mmol/L) | Standard Deviation 0.415 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Potassium | 4.35 millimoles per liter (mmol/L) | Standard Deviation 0.282 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Glucose | 4.86 millimoles per liter (mmol/L) | Standard Deviation 0.271 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Potassium | 4.35 millimoles per liter (mmol/L) | Standard Deviation 0.241 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Glucose | 4.72 millimoles per liter (mmol/L) | Standard Deviation 0.356 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Potassium | 4.24 millimoles per liter (mmol/L) | Standard Deviation 0.294 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Glucose | 4.49 millimoles per liter (mmol/L) | Standard Deviation 0.243 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Potassium | 4.24 millimoles per liter (mmol/L) | Standard Deviation 0.191 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Glucose | 4.65 millimoles per liter (mmol/L) | Standard Deviation 0.237 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.149 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Glucose | 4.93 millimoles per liter (mmol/L) | Standard Deviation 0.758 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Potassium | 4.49 millimoles per liter (mmol/L) | Standard Deviation 0.487 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Glucose | 4.93 millimoles per liter (mmol/L) | Standard Deviation 0.588 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Potassium | 4.32 millimoles per liter (mmol/L) | Standard Deviation 0.256 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Glucose | 4.91 millimoles per liter (mmol/L) | Standard Deviation 0.488 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.144 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Glucose | 4.78 millimoles per liter (mmol/L) | Standard Deviation 0.431 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Potassium | 4.16 millimoles per liter (mmol/L) | Standard Deviation 0.185 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Glucose | 4.61 millimoles per liter (mmol/L) | Standard Deviation 0.427 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.255 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Glucose | 4.53 millimoles per liter (mmol/L) | Standard Deviation 0.355 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Potassium | 4.16 millimoles per liter (mmol/L) | Standard Deviation 0.163 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Glucose | 4.59 millimoles per liter (mmol/L) | Standard Deviation 0.232 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Potassium | 4.46 millimoles per liter (mmol/L) | Standard Deviation 0.301 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Glucose | 5.02 millimoles per liter (mmol/L) | Standard Deviation 0.895 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.144 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Glucose | 4.88 millimoles per liter (mmol/L) | Standard Deviation 0.68 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Glucose | 4.68 millimoles per liter (mmol/L) | Standard Deviation 0.449 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.328 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Glucose | 4.72 millimoles per liter (mmol/L) | Standard Deviation 0.369 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Potassium | 4.37 millimoles per liter (mmol/L) | Standard Deviation 0.793 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Glucose | 4.49 millimoles per liter (mmol/L) | Standard Deviation 0.286 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.214 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Glucose | 4.51 millimoles per liter (mmol/L) | Standard Deviation 0.299 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.264 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Glucose | 4.66 millimoles per liter (mmol/L) | Standard Deviation 0.166 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.258 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Glucose | 4.99 millimoles per liter (mmol/L) | Standard Deviation 0.856 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Potassium | 4.24 millimoles per liter (mmol/L) | Standard Deviation 0.175 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Glucose | 4.98 millimoles per liter (mmol/L) | Standard Deviation 0.938 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.141 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Glucose | 4.92 millimoles per liter (mmol/L) | Standard Deviation 0.518 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Potassium | 4.24 millimoles per liter (mmol/L) | Standard Deviation 0.213 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Glucose | 4.86 millimoles per liter (mmol/L) | Standard Deviation 0.548 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.327 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Glucose | 4.59 millimoles per liter (mmol/L) | Standard Deviation 0.278 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.253 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Glucose | 4.48 millimoles per liter (mmol/L) | Standard Deviation 0.239 |
Secondary
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Calcium: Baseline (Day -1) | 2.388 millimoles per liter (mmol/L) | Standard Deviation 0.0561 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Calcium: Day 11 (Discharge) | 2.300 millimoles per liter (mmol/L) | Standard Deviation 0.0515 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Sodium: Baseline (Day -1) | 139.7 millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Sodium: Day 11 (Discharge) | 139.7 millimoles per liter (mmol/L) | Standard Deviation 0.9 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Urea Nitrogen: Baseline (Day -1) | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.945 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Urea Nitrogen: Day 11 (Discharge) | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.837 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Urea Nitrogen: Baseline (Day -1) | 4.54 millimoles per liter (mmol/L) | Standard Deviation 1.149 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Calcium: Baseline (Day -1) | 2.431 millimoles per liter (mmol/L) | Standard Deviation 0.0656 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Sodium: Day 11 (Discharge) | 140.3 millimoles per liter (mmol/L) | Standard Deviation 1.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Calcium: Day 11 (Discharge) | 2.306 millimoles per liter (mmol/L) | Standard Deviation 0.0678 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Urea Nitrogen: Day 11 (Discharge) | 4.17 millimoles per liter (mmol/L) | Standard Deviation 0.832 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Sodium: Baseline (Day -1) | 139.7 millimoles per liter (mmol/L) | Standard Deviation 1.38 |
Secondary
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALT: Baseline (Day -1) | 21.67 International Units per Liter (IU/L) | Standard Deviation 9.108 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALT: Day 11 (Discharge) | 19.33 International Units per Liter (IU/L) | Standard Deviation 5.327 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALP: Baseline (Day -1) | 65.4 International Units per Liter (IU/L) | Standard Deviation 14.26 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALP: Day 11 (Discharge) | 60.5 International Units per Liter (IU/L) | Standard Deviation 15.85 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | AST: Baseline (Day -1) | 12.38 International Units per Liter (IU/L) | Standard Deviation 3.984 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | AST: Day 11 (Discharge) | 10.49 International Units per Liter (IU/L) | Standard Deviation 3.01 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | CPK: Baseline (Day -1) | 103.1 International Units per Liter (IU/L) | Standard Deviation 44.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | CPK: Day 11 (Discharge) | 88.1 International Units per Liter (IU/L) | Standard Deviation 61.28 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | CPK: Day 11 (Discharge) | 79.9 International Units per Liter (IU/L) | Standard Deviation 32.26 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALT: Baseline (Day -1) | 23.22 International Units per Liter (IU/L) | Standard Deviation 10.178 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | AST: Baseline (Day -1) | 14.52 International Units per Liter (IU/L) | Standard Deviation 5.611 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALT: Day 11 (Discharge) | 21.45 International Units per Liter (IU/L) | Standard Deviation 8.102 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | CPK: Baseline (Day -1) | 120.4 International Units per Liter (IU/L) | Standard Deviation 60.49 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALP: Baseline (Day -1) | 73.1 International Units per Liter (IU/L) | Standard Deviation 17.89 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | AST: Day 11 (Discharge) | 11.66 International Units per Liter (IU/L) | Standard Deviation 4.24 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | ALP: Day 11 (Discharge) | 64.4 International Units per Liter (IU/L) | Standard Deviation 12.41 |
Secondary
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Direct Bilirubin: Baseline (Day -1) | 4.12 micromoles per liter (umol/L) | Standard Deviation 2.214 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Direct Bilirubin: Day 11 (Discharge) | 3.79 micromoles per liter (umol/L) | Standard Deviation 2.055 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Bilirubin: Baseline (Day -1) | 12.2 micromoles per liter (umol/L) | Standard Deviation 6.22 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Bilirubin: Day 11 (Discharge) | 11.8 micromoles per liter (umol/L) | Standard Deviation 5.82 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Protein: Baseline (Day -1) | 74.1 micromoles per liter (umol/L) | Standard Deviation 3.75 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Protein: Day 11 (Discharge) | 68.2 micromoles per liter (umol/L) | Standard Deviation 3.59 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Creatinine: Baseline (Day -1) | 63.3 micromoles per liter (umol/L) | Standard Deviation 12.48 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Creatinine: Day 11 (Discharge) | 62.1 micromoles per liter (umol/L) | Standard Deviation 10.92 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Creatinine: Day 11 (Discharge) | 69.4 micromoles per liter (umol/L) | Standard Deviation 15.33 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Direct Bilirubin: Baseline (Day -1) | 4.85 micromoles per liter (umol/L) | Standard Deviation 2.035 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Protein: Baseline (Day -1) | 73.3 micromoles per liter (umol/L) | Standard Deviation 4.19 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Direct Bilirubin: Day 11 (Discharge) | 4.15 micromoles per liter (umol/L) | Standard Deviation 1.531 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Creatinine: Baseline (Day -1) | 73.6 micromoles per liter (umol/L) | Standard Deviation 18.33 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Bilirubin: Baseline (Day -1) | 16.3 micromoles per liter (umol/L) | Standard Deviation 7.1 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Protein: Day 11 (Discharge) | 66.9 micromoles per liter (umol/L) | Standard Deviation 3.4 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Total Bilirubin: Day 11 (Discharge) | 13.8 micromoles per liter (umol/L) | Standard Deviation 5.89 |
Secondary
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) | 4.890 Trillion cells/Liter | Standard Deviation 0.4431 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes | Day 11 (Discharge) | 4.516 Trillion cells/Liter | Standard Deviation 0.471 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) | 5.158 Trillion cells/Liter | Standard Deviation 0.4141 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes | Day 11 (Discharge) | 4.753 Trillion cells/Liter | Standard Deviation 0.4655 |
Secondary
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) | 0.445 Percentage of red blood cells in blood | Standard Deviation 0.0405 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Hematocrit | Day 11 (Discharge) | 0.405 Percentage of red blood cells in blood | Standard Deviation 0.0426 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) | 0.475 Percentage of red blood cells in blood | Standard Deviation 0.0355 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Hematocrit | Day 11 (Discharge) | 0.433 Percentage of red blood cells in blood | Standard Deviation 0.0392 |
Secondary
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) | 143.19 gram per liter (g/L) | Standard Deviation 14.903 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin | Day 11 (Discharge) | 132.77 gram per liter (g/L) | Standard Deviation 14.593 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) | 153.08 gram per liter (g/L) | Standard Deviation 11.699 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin | Day 11 (Discharge) | 140.94 gram per liter (g/L) | Standard Deviation 12.026 |
Secondary
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) | 1.817 femtomole (fmol) | Standard Deviation 0.0977 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Day 11 (Discharge) | 1.823 femtomole (fmol) | Standard Deviation 0.1077 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) | 1.845 femtomole (fmol) | Standard Deviation 0.0599 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Day 11 (Discharge) | 1.841 femtomole (fmol) | Standard Deviation 0.064 |
Secondary
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) | 91.1 femtoliter (fL) | Standard Deviation 4.61 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Day 11 (Discharge) | 90.0 femtoliter (fL) | Standard Deviation 4.26 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) | 92.1 femtoliter (fL) | Standard Deviation 3.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Day 11 (Discharge) | 91.6 femtoliter (fL) | Standard Deviation 2.5 |
Secondary
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Baseline (Day -1) | 3.62 Giga cells/Liter | Standard Deviation 1.058 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Day 11 (Discharge) | 3.05 Giga cells/Liter | Standard Deviation 0.829 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Baseline (Day -1) | 2.07 Giga cells/Liter | Standard Deviation 0.437 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Day 11 (Discharge) | 2.08 Giga cells/Liter | Standard Deviation 0.707 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Baseline (Day -1) | 0.33 Giga cells/Liter | Standard Deviation 0.062 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Day 11 (Discharge) | 0.28 Giga cells/Liter | Standard Deviation 0.094 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Baseline (Day -1) | 0.13 Giga cells/Liter | Standard Deviation 0.046 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Day 11 (Discharge) | 0.11 Giga cells/Liter | Standard Deviation 0.035 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Baseline (Day -1) | 0.03 Giga cells/Liter | Standard Deviation 0.049 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Day 11 (Discharge) | 0.03 Giga cells/Liter | Standard Deviation 0.049 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Baseline (Day -1) | 254.9 Giga cells/Liter | Standard Deviation 45.61 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Day 11 (Discharge) | 252.1 Giga cells/Liter | Standard Deviation 40.26 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Baseline (Day -1) | 262.8 Giga cells/Liter | Standard Deviation 63.27 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Baseline (Day -1) | 3.32 Giga cells/Liter | Standard Deviation 1.271 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Baseline (Day -1) | 0.16 Giga cells/Liter | Standard Deviation 0.077 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Day 11 (Discharge) | 2.95 Giga cells/Liter | Standard Deviation 0.918 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Day 11 (Discharge) | 0.03 Giga cells/Liter | Standard Deviation 0.048 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Baseline (Day -1) | 1.97 Giga cells/Liter | Standard Deviation 0.654 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Day 11 (Discharge) | 0.15 Giga cells/Liter | Standard Deviation 0.052 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Day 11 (Discharge) | 1.88 Giga cells/Liter | Standard Deviation 0.472 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Day 11 (Discharge) | 230.6 Giga cells/Liter | Standard Deviation 50.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Baseline (Day -1) | 0.33 Giga cells/Liter | Standard Deviation 0.075 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Baseline (Day -1) | 0.05 Giga cells/Liter | Standard Deviation 0.052 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Day 11 (Discharge) | 0.32 Giga cells/Liter | Standard Deviation 0.08 |
Secondary
Cohort 1: Absolute Values of Pulse Rate (PR)
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 1 [Period 1]) | 55.7 Beats per minute | Standard Deviation 7.07 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 4 hours (Period 2) | 57.1 Beats per minute | Standard Deviation 6.41 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 4 hours (Period 1) | 55.8 Beats per minute | Standard Deviation 7.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 7 [Period 3]) | 54.7 Beats per minute | Standard Deviation 7.34 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 30 minutes (Period 3) | 65.3 Beats per minute | Standard Deviation 7.43 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 30 minutes (Period 1) | 61.9 Beats per minute | Standard Deviation 7.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 1 hour (Period 3) | 63.6 Beats per minute | Standard Deviation 7.62 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 4 [Period 2]) | 52.7 Beats per minute | Standard Deviation 7.17 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 2 hours (Period 3) | 59.0 Beats per minute | Standard Deviation 5.8 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 15 minutes (Period 3) | 69.2 Beats per minute | Standard Deviation 10.98 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 4 hours (Period 3) | 59.8 Beats per minute | Standard Deviation 5.74 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 15 minutes (Period 2) | 64.7 Beats per minute | Standard Deviation 5.31 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 15 minutes (Period 4) | 67.5 Beats per minute | Standard Deviation 7.24 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 1 hour (Period 1) | 60.0 Beats per minute | Standard Deviation 7.87 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 30 minutes (Period 4) | 65.3 Beats per minute | Standard Deviation 9.8 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 30 minutes (Period 2) | 62.8 Beats per minute | Standard Deviation 6.6 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 1 hour (Period 4) | 63.7 Beats per minute | Standard Deviation 7.82 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 15 minutes (Period 1) | 63.9 Beats per minute | Standard Deviation 8.07 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 2 hours (Period 4) | 58.1 Beats per minute | Standard Deviation 6.92 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 1 hour (Period 2) | 62.1 Beats per minute | Standard Deviation 7.24 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 4 hours (Period 4) | 58.6 Beats per minute | Standard Deviation 7.81 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 2 hours (Period 1) | 57.7 Beats per minute | Standard Deviation 9.17 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 2 hours (Period 2) | 57.1 Beats per minute | Standard Deviation 5.2 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 10 (Period 4) | 55.6 Beats per minute | Standard Deviation 8.56 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 1 hour (Period 4) | 62.1 Beats per minute | Standard Deviation 9.12 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 15 minutes (Period 3) | 65.6 Beats per minute | Standard Deviation 9.18 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 1 [Period 1]) | 51.1 Beats per minute | Standard Deviation 6.27 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 15 minutes (Period 1) | 65.3 Beats per minute | Standard Deviation 9.14 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 30 minutes (Period 1) | 63.6 Beats per minute | Standard Deviation 10.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 1 hour (Period 1) | 58.7 Beats per minute | Standard Deviation 7.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 2 hours (Period 1) | 54.9 Beats per minute | Standard Deviation 6.79 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 4 hours (Period 1) | 53.6 Beats per minute | Standard Deviation 6.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 4 [Period 2]) | 54.4 Beats per minute | Standard Deviation 8.55 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 15 minutes (Period 2) | 65.3 Beats per minute | Standard Deviation 6.87 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 30 minutes (Period 2) | 64.1 Beats per minute | Standard Deviation 4.44 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 1 hour (Period 2) | 59.3 Beats per minute | Standard Deviation 7.11 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 2 hours (Period 2) | 56.8 Beats per minute | Standard Deviation 8.64 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 4 hours (Period 2) | 57.9 Beats per minute | Standard Deviation 10.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 30 minutes (Period 3) | 62.6 Beats per minute | Standard Deviation 8.41 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 1 hour (Period 3) | 61.6 Beats per minute | Standard Deviation 6.73 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 2 hours (Period 3) | 57.5 Beats per minute | Standard Deviation 7.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 10 (Period 4) | 54.5 Beats per minute | Standard Deviation 5.61 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 15 minutes (Period 4) | 68.0 Beats per minute | Standard Deviation 9.7 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 30 minutes (Period 4) | 63.4 Beats per minute | Standard Deviation 7.98 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 7 [Period 3]) | 56.8 Beats per minute | Standard Deviation 6.01 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 2 hours (Period 4) | 58.9 Beats per minute | Standard Deviation 8.41 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 4 hours (Period 4) | 56.8 Beats per minute | Standard Deviation 7.51 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 4 hours (Period 3) | 57.6 Beats per minute | Standard Deviation 9.26 |
Secondary
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), SBP | 110.3 millimeters of mercury (mmHg) | Standard Deviation 8.09 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), SBP | 109.9 millimeters of mercury (mmHg) | Standard Deviation 10.19 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), SBP | 112.2 millimeters of mercury (mmHg) | Standard Deviation 8.84 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), SBP | 107.9 millimeters of mercury (mmHg) | Standard Deviation 11.74 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), SBP | 107.9 millimeters of mercury (mmHg) | Standard Deviation 9.39 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), SBP | 106.8 millimeters of mercury (mmHg) | Standard Deviation 9.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), SBP | 110.2 millimeters of mercury (mmHg) | Standard Deviation 10.16 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), SBP | 113.6 millimeters of mercury (mmHg) | Standard Deviation 7.52 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), SBP | 113.9 millimeters of mercury (mmHg) | Standard Deviation 7.53 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), SBP | 113.0 millimeters of mercury (mmHg) | Standard Deviation 9.99 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), SBP | 110.4 millimeters of mercury (mmHg) | Standard Deviation 11.66 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), SBP | 109.3 millimeters of mercury (mmHg) | Standard Deviation 9 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), SBP | 108.6 millimeters of mercury (mmHg) | Standard Deviation 6.83 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), SBP | 111.8 millimeters of mercury (mmHg) | Standard Deviation 6.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), SBP | 116.4 millimeters of mercury (mmHg) | Standard Deviation 7.55 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), SBP | 113.2 millimeters of mercury (mmHg) | Standard Deviation 7.16 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), SBP | 107.4 millimeters of mercury (mmHg) | Standard Deviation 8.38 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), SBP | 110.5 millimeters of mercury (mmHg) | Standard Deviation 7.89 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), SBP | 108.0 millimeters of mercury (mmHg) | Standard Deviation 9.06 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), SBP | 107.1 millimeters of mercury (mmHg) | Standard Deviation 9.63 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), SBP | 109.1 millimeters of mercury (mmHg) | Standard Deviation 9.93 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), SBP | 106.7 millimeters of mercury (mmHg) | Standard Deviation 10.72 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), SBP | 104.5 millimeters of mercury (mmHg) | Standard Deviation 7.36 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), SBP | 105.1 millimeters of mercury (mmHg) | Standard Deviation 12.34 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), DBP | 65.6 millimeters of mercury (mmHg) | Standard Deviation 4.47 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), DBP | 62.7 millimeters of mercury (mmHg) | Standard Deviation 6.19 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), DBP | 65.5 millimeters of mercury (mmHg) | Standard Deviation 5.32 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), DBP | 62.7 millimeters of mercury (mmHg) | Standard Deviation 5.56 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), DBP | 63.4 millimeters of mercury (mmHg) | Standard Deviation 4.84 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), DBP | 63.3 millimeters of mercury (mmHg) | Standard Deviation 5.35 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), DBP | 64.1 millimeters of mercury (mmHg) | Standard Deviation 4.24 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), DBP | 64.9 millimeters of mercury (mmHg) | Standard Deviation 4.14 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), DBP | 63.9 millimeters of mercury (mmHg) | Standard Deviation 4.51 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), DBP | 62.1 millimeters of mercury (mmHg) | Standard Deviation 5.46 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), DBP | 63.3 millimeters of mercury (mmHg) | Standard Deviation 6.09 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), DBP | 61.4 millimeters of mercury (mmHg) | Standard Deviation 5.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), DBP | 68.1 millimeters of mercury (mmHg) | Standard Deviation 4.91 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), DBP | 63.6 millimeters of mercury (mmHg) | Standard Deviation 5.53 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), DBP | 64.7 millimeters of mercury (mmHg) | Standard Deviation 4.91 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), DBP | 64.4 millimeters of mercury (mmHg) | Standard Deviation 4.94 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), DBP | 60.7 millimeters of mercury (mmHg) | Standard Deviation 5.22 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), DBP | 63.9 millimeters of mercury (mmHg) | Standard Deviation 4.75 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), DBP | 63.4 millimeters of mercury (mmHg) | Standard Deviation 5.44 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), DBP | 62.9 millimeters of mercury (mmHg) | Standard Deviation 5.19 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), DBP | 63.4 millimeters of mercury (mmHg) | Standard Deviation 5.85 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), DBP | 62.5 millimeters of mercury (mmHg) | Standard Deviation 5.97 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), DBP | 63.2 millimeters of mercury (mmHg) | Standard Deviation 8.79 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), DBP | 66.1 millimeters of mercury (mmHg) | Standard Deviation 6.46 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), DBP | 65.1 millimeters of mercury (mmHg) | Standard Deviation 3.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), SBP | 111.9 millimeters of mercury (mmHg) | Standard Deviation 7.24 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), DBP | 67.8 millimeters of mercury (mmHg) | Standard Deviation 6.81 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), SBP | 113.9 millimeters of mercury (mmHg) | Standard Deviation 4.83 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), DBP | 65.0 millimeters of mercury (mmHg) | Standard Deviation 4.38 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), SBP | 115.9 millimeters of mercury (mmHg) | Standard Deviation 6.54 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), DBP | 66.0 millimeters of mercury (mmHg) | Standard Deviation 3.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), SBP | 112.6 millimeters of mercury (mmHg) | Standard Deviation 7.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), DBP | 62.0 millimeters of mercury (mmHg) | Standard Deviation 4.16 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), SBP | 107.6 millimeters of mercury (mmHg) | Standard Deviation 6.55 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), DBP | 66.4 millimeters of mercury (mmHg) | Standard Deviation 5.02 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), SBP | 109.1 millimeters of mercury (mmHg) | Standard Deviation 7.92 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), DBP | 60.7 millimeters of mercury (mmHg) | Standard Deviation 5.19 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), SBP | 104.9 millimeters of mercury (mmHg) | Standard Deviation 8.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), DBP | 63.0 millimeters of mercury (mmHg) | Standard Deviation 5.66 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), SBP | 108.3 millimeters of mercury (mmHg) | Standard Deviation 8.12 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), DBP | 64.6 millimeters of mercury (mmHg) | Standard Deviation 6.36 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), SBP | 112.1 millimeters of mercury (mmHg) | Standard Deviation 11.79 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), DBP | 63.5 millimeters of mercury (mmHg) | Standard Deviation 4.9 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), SBP | 107.5 millimeters of mercury (mmHg) | Standard Deviation 7.69 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), DBP | 62.3 millimeters of mercury (mmHg) | Standard Deviation 4.58 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), SBP | 104.5 millimeters of mercury (mmHg) | Standard Deviation 8.93 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), DBP | 63.4 millimeters of mercury (mmHg) | Standard Deviation 5.29 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), SBP | 104.3 millimeters of mercury (mmHg) | Standard Deviation 9.29 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), DBP | 63.0 millimeters of mercury (mmHg) | Standard Deviation 3.92 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), SBP | 103.3 millimeters of mercury (mmHg) | Standard Deviation 9.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), DBP | 65.3 millimeters of mercury (mmHg) | Standard Deviation 5.74 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), SBP | 106.4 millimeters of mercury (mmHg) | Standard Deviation 8.63 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), DBP | 60.9 millimeters of mercury (mmHg) | Standard Deviation 5.14 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), SBP | 108.6 millimeters of mercury (mmHg) | Standard Deviation 10.65 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), DBP | 63.9 millimeters of mercury (mmHg) | Standard Deviation 6.46 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), SBP | 104.3 millimeters of mercury (mmHg) | Standard Deviation 7.67 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), DBP | 66.5 millimeters of mercury (mmHg) | Standard Deviation 6.7 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), SBP | 102.4 millimeters of mercury (mmHg) | Standard Deviation 9.85 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), DBP | 64.8 millimeters of mercury (mmHg) | Standard Deviation 7.33 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), SBP | 102.3 millimeters of mercury (mmHg) | Standard Deviation 9.26 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), DBP | 62.3 millimeters of mercury (mmHg) | Standard Deviation 6.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), SBP | 111.2 millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), DBP | 63.8 millimeters of mercury (mmHg) | Standard Deviation 6.38 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), SBP | 114.2 millimeters of mercury (mmHg) | Standard Deviation 10.43 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), DBP | 62.8 millimeters of mercury (mmHg) | Standard Deviation 4.93 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), SBP | 115.2 millimeters of mercury (mmHg) | Standard Deviation 8.41 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), DBP | 63.3 millimeters of mercury (mmHg) | Standard Deviation 5.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), SBP | 112.6 millimeters of mercury (mmHg) | Standard Deviation 7.31 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), DBP | 61.6 millimeters of mercury (mmHg) | Standard Deviation 7.35 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), SBP | 106.1 millimeters of mercury (mmHg) | Standard Deviation 7.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), DBP | 62.9 millimeters of mercury (mmHg) | Standard Deviation 4.24 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), SBP | 110.3 millimeters of mercury (mmHg) | Standard Deviation 6.45 |
Secondary
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 1 | 7.83 Hour (h) | Standard Deviation 1.093 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 7 | 7.92 Hour (h) | Standard Deviation 2.257 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 4 | 7.62 Hour (h) | Standard Deviation 0.904 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 10 | 8.17 Hour (h) | Standard Deviation 1.377 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 4 | 7.43 Hour (h) | Standard Deviation 1.546 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 1 | 7.50 Hour (h) | Standard Deviation 1.731 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 10 | 7.22 Hour (h) | Standard Deviation 1.319 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Apparent Terminal Phase Half-life (t1/2) | Day 7 | 7.35 Hour (h) | Standard Deviation 1.388 |
Secondary
Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | 5120.73 h*pg/mL |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | 3977.02 h*pg/mL |
Secondary
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 8.6 Beats per minute | Standard Deviation 3.4 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | 8.3 Beats per minute | Standard Deviation 5.74 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 12.5 Beats per minute | Standard Deviation 7.62 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Day 11 (Discharge) | 4.1 Beats per minute | Standard Deviation 7.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | 8.0 Beats per minute | Standard Deviation 4.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Day 11 (Discharge) | 7.5 Beats per minute | Standard Deviation 6.69 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | 10.0 Beats per minute | Standard Deviation 3.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 7.8 Beats per minute | Standard Deviation 6.43 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 5.7 Beats per minute | Standard Deviation 4.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | 10.4 Beats per minute | Standard Deviation 4.79 |
Secondary
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | -6.6 milliseconds (ms) | Standard Deviation 12.78 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | -11.5 milliseconds (ms) | Standard Deviation 4.83 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | -8.9 milliseconds (ms) | Standard Deviation 8.69 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | -4.9 milliseconds (ms) | Standard Deviation 12.68 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Day 11 (Discharge) | -8.7 milliseconds (ms) | Standard Deviation 9.29 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | -7.5 milliseconds (ms) | Standard Deviation 9.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | -9.2 milliseconds (ms) | Standard Deviation 6.89 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Day 11 (Discharge) | -8.5 milliseconds (ms) | Standard Deviation 9.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | -5.9 milliseconds (ms) | Standard Deviation 13.26 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | -11.3 milliseconds (ms) | Standard Deviation 8.52 |
Secondary
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Population: Safety Population included all participants who received at least one puff/actuation of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 18 Participants |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 1 Participants |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 12 Participants |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
Secondary
Cohort 1-Intra-Participant Variability of AUC (0-30min)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1-Intra-Participant Variability of AUC (0-30min) | 36.3 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1-Intra-Participant Variability of AUC (0-30min) | 28.7 Percentage of Coefficient Variation |
Secondary
Cohort 1: Intra Participant Variability of AUC (0-infinity)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Intra Participant Variability of AUC (0-infinity) | 28.3 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Intra Participant Variability of AUC (0-infinity) | 18.6 Percentage of Coefficient Variation |
Secondary
Cohort 1: Intra Participant Variability of AUC(0-last)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Intra Participant Variability of AUC(0-last) | 28.5 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Intra Participant Variability of AUC(0-last) | 18.3 Percentage of Coefficient Variation |
Secondary
Cohort 1: Intra Participant Variability of Cmax
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Intra Participant Variability of Cmax | 33.5 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Intra Participant Variability of Cmax | 17.3 Percentage of Coefficient Variation |
Secondary
Cohort 1: Time to Reach Cmax (Tmax)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Time to Reach Cmax (Tmax) | Day 1 | 2.00 Hour (h) |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Time to Reach Cmax (Tmax) | Day 4 | 1.25 Hour (h) |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Time to Reach Cmax (Tmax) | Day 7 | 1.50 Hour (h) |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 1: Time to Reach Cmax (Tmax) | Day 10 | 1.50 Hour (h) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Time to Reach Cmax (Tmax) | Day 10 | 1.00 Hour (h) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Time to Reach Cmax (Tmax) | Day 1 | 2.0 Hour (h) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Time to Reach Cmax (Tmax) | Day 7 | 1.50 Hour (h) |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 1: Time to Reach Cmax (Tmax) | Day 4 | 1.00 Hour (h) |
Secondary
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 7 [Period 3]) | 399.9 milliseconds (ms) | Standard Deviation 24.76 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 1 (Period 1) | 400.8 milliseconds (ms) | Standard Deviation 17.71 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 4 [Period 2]) | 398.9 milliseconds (ms) | Standard Deviation 25.14 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 4 (Period 2) | 399.6 milliseconds (ms) | Standard Deviation 23.18 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 7 (Period 3) | 402.5 milliseconds (ms) | Standard Deviation 23.59 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 10 [Period 4]) | 401.8 milliseconds (ms) | Standard Deviation 15.07 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 10 (Period 4) | 400.2 milliseconds (ms) | Standard Deviation 12.76 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Day 11 (Discharge) | 395.9 milliseconds (ms) | Standard Deviation 18.19 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 1 [Period 1]) | 407.8 milliseconds (ms) | Standard Deviation 17.31 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Day 11 (Discharge) | 391.2 milliseconds (ms) | Standard Deviation 22.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 1 [Period 1]) | 399.9 milliseconds (ms) | Standard Deviation 21.05 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 7 (Period 3) | 407.8 milliseconds (ms) | Standard Deviation 24.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 1 (Period 1) | 402.9 milliseconds (ms) | Standard Deviation 18.43 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 10 (Period 4) | 400.6 milliseconds (ms) | Standard Deviation 22.53 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 4 [Period 2]) | 401.9 milliseconds (ms) | Standard Deviation 17.55 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 10 [Period 4]) | 397.7 milliseconds (ms) | Standard Deviation 22.86 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Post-dose at 30 minutes on Day 4 (Period 2) | 401.9 milliseconds (ms) | Standard Deviation 19.28 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals | Baseline (Pre-dose at Day 7 [Period 3]) | 402.7 milliseconds (ms) | Standard Deviation 17.59 |
Secondary
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 4 (Period 2) | 66.7 Beats per minute | Standard Deviation 8.67 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 10 [Period 4]) | 64.1 Beats per minute | Standard Deviation 9.09 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 1 (Period 1) | 75.9 Beats per minute | Standard Deviation 14.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 10 (Period 4) | 77.1 Beats per minute | Standard Deviation 11.11 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 7 [Period 3]) | 55.1 Beats per minute | Standard Deviation 8.38 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Day 11 (Discharge) | 67.8 Beats per minute | Standard Deviation 10.68 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 7 (Period 3) | 66.7 Beats per minute | Standard Deviation 8.65 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 4 [Period 2]) | 54.5 Beats per minute | Standard Deviation 7.76 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 1 [Period 1]) | 63.9 Beats per minute | Standard Deviation 13.1 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 7 [Period 3]) | 64.1 Beats per minute | Standard Deviation 10.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 1 [Period 1]) | 53.2 Beats per minute | Standard Deviation 7.91 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 1 (Period 1) | 66.4 Beats per minute | Standard Deviation 7.27 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 4 [Period 2]) | 61.4 Beats per minute | Standard Deviation 9.38 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 4 (Period 2) | 76.4 Beats per minute | Standard Deviation 13.83 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 7 (Period 3) | 75.2 Beats per minute | Standard Deviation 10.17 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Baseline (Pre-dose at Day 10 [Period 4]) | 55.4 Beats per minute | Standard Deviation 8.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Post-dose at 30 minutes on Day 10 (Period 4) | 68.4 Beats per minute | Standard Deviation 9.49 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) | Day 11 (Discharge) | 59.4 Beats per minute | Standard Deviation 10.65 |
Secondary
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Blood samples were collected for analyzing absolute values of glucose and potassium
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Glucose | 4.84 millimoles per liter (mmol/L) | Standard Deviation 0.242 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Glucose | 5.04 millimoles per liter (mmol/L) | Standard Deviation 0.804 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Glucose | 5.08 millimoles per liter (mmol/L) | Standard Deviation 0.558 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Glucose | 5.26 millimoles per liter (mmol/L) | Standard Deviation 0.403 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Glucose | 5.09 millimoles per liter (mmol/L) | Standard Deviation 0.474 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Glucose | 4.94 millimoles per liter (mmol/L) | Standard Deviation 0.422 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Glucose | 4.59 millimoles per liter (mmol/L) | Standard Deviation 0.297 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Glucose | 4.81 millimoles per liter (mmol/L) | Standard Deviation 0.253 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Glucose | 4.97 millimoles per liter (mmol/L) | Standard Deviation 1.605 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Glucose | 4.89 millimoles per liter (mmol/L) | Standard Deviation 1.056 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Glucose | 4.88 millimoles per liter (mmol/L) | Standard Deviation 0.473 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Glucose | 4.92 millimoles per liter (mmol/L) | Standard Deviation 0.55 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Glucose | 4.74 millimoles per liter (mmol/L) | Standard Deviation 0.334 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Glucose | 4.66 millimoles per liter (mmol/L) | Standard Deviation 0.225 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Glucose | 4.84 millimoles per liter (mmol/L) | Standard Deviation 0.303 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Glucose | 5.01 millimoles per liter (mmol/L) | Standard Deviation 0.936 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Glucose | 4.75 millimoles per liter (mmol/L) | Standard Deviation 0.516 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Glucose | 4.84 millimoles per liter (mmol/L) | Standard Deviation 0.426 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Glucose | 4.73 millimoles per liter (mmol/L) | Standard Deviation 0.382 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Glucose | 4.66 millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Glucose | 4.71 millimoles per liter (mmol/L) | Standard Deviation 0.154 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Glucose | 4.67 millimoles per liter (mmol/L) | Standard Deviation 0.293 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Glucose | 4.62 millimoles per liter (mmol/L) | Standard Deviation 0.887 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Glucose | 4.77 millimoles per liter (mmol/L) | Standard Deviation 0.786 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Glucose | 4.88 millimoles per liter (mmol/L) | Standard Deviation 0.285 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Glucose | 4.81 millimoles per liter (mmol/L) | Standard Deviation 0.411 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Glucose | 4.62 millimoles per liter (mmol/L) | Standard Deviation 0.349 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Glucose | 4.59 millimoles per liter (mmol/L) | Standard Deviation 0.355 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.212 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Potassium | 4.36 millimoles per liter (mmol/L) | Standard Deviation 0.365 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.301 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Potassium | 4.22 millimoles per liter (mmol/L) | Standard Deviation 0.345 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.277 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Potassium | 4.30 millimoles per liter (mmol/L) | Standard Deviation 0.499 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.142 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.191 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Potassium | 4.37 millimoles per liter (mmol/L) | Standard Deviation 0.235 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Potassium | 4.31 millimoles per liter (mmol/L) | Standard Deviation 0.241 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Potassium | 4.19 millimoles per liter (mmol/L) | Standard Deviation 0.161 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Potassium | 4.11 millimoles per liter (mmol/L) | Standard Deviation 0.139 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.515 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Potassium | 4.14 millimoles per liter (mmol/L) | Standard Deviation 0.271 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.142 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.153 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Potassium | 4.21 millimoles per liter (mmol/L) | Standard Deviation 0.216 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Potassium | 4.14 millimoles per liter (mmol/L) | Standard Deviation 0.178 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Potassium | 4.27 millimoles per liter (mmol/L) | Standard Deviation 0.613 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.18 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.279 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Potassium | 4.52 millimoles per liter (mmol/L) | Standard Deviation 0.44 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Potassium | 4.22 millimoles per liter (mmol/L) | Standard Deviation 0.249 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Potassium | 4.40 millimoles per liter (mmol/L) | Standard Deviation 0.422 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Potassium | 4.22 millimoles per liter (mmol/L) | Standard Deviation 0.231 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Potassium | 4.17 millimoles per liter (mmol/L) | Standard Deviation 0.18 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Potassium | 4.22 millimoles per liter (mmol/L) | Standard Deviation 0.228 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Potassium | 4.15 millimoles per liter (mmol/L) | Standard Deviation 0.194 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.171 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Glucose | 4.99 millimoles per liter (mmol/L) | Standard Deviation 0.336 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 1 [Period 1]), Potassium | 4.39 millimoles per liter (mmol/L) | Standard Deviation 0.295 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Glucose | 4.96 millimoles per liter (mmol/L) | Standard Deviation 1.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Potassium | 4.30 millimoles per liter (mmol/L) | Standard Deviation 0.153 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Glucose | 4.96 millimoles per liter (mmol/L) | Standard Deviation 0.623 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 15 minutes (Period 1), Potassium | 4.32 millimoles per liter (mmol/L) | Standard Deviation 0.128 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Glucose | 4.96 millimoles per liter (mmol/L) | Standard Deviation 0.32 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Potassium | 4.35 millimoles per liter (mmol/L) | Standard Deviation 0.234 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Glucose | 4.98 millimoles per liter (mmol/L) | Standard Deviation 0.277 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 30 minutes (Period 1), Potassium | 4.37 millimoles per liter (mmol/L) | Standard Deviation 0.296 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Glucose | 4.88 millimoles per liter (mmol/L) | Standard Deviation 0.349 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Potassium | 4.25 millimoles per liter (mmol/L) | Standard Deviation 0.185 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Glucose | 4.74 millimoles per liter (mmol/L) | Standard Deviation 0.239 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1 hour (Period 1), Potassium | 4.23 millimoles per liter (mmol/L) | Standard Deviation 0.14 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Glucose | 4.74 millimoles per liter (mmol/L) | Standard Deviation 0.334 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Potassium | 4.07 millimoles per liter (mmol/L) | Standard Deviation 0.162 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Glucose | 4.72 millimoles per liter (mmol/L) | Standard Deviation 0.998 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 1.5 hours (Period 1), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.402 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Glucose | 4.96 millimoles per liter (mmol/L) | Standard Deviation 0.658 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Potassium | 4.31 millimoles per liter (mmol/L) | Standard Deviation 0.218 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Glucose | 4.97 millimoles per liter (mmol/L) | Standard Deviation 0.397 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 2 hours (Period 1), Potassium | 4.16 millimoles per liter (mmol/L) | Standard Deviation 0.131 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Glucose | 4.78 millimoles per liter (mmol/L) | Standard Deviation 0.444 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Potassium | 4.29 millimoles per liter (mmol/L) | Standard Deviation 0.294 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Glucose | 4.54 millimoles per liter (mmol/L) | Standard Deviation 0.371 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 1: Post-dose at 4 hours (Period 1), Potassium | 4.06 millimoles per liter (mmol/L) | Standard Deviation 0.163 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Glucose | 4.52 millimoles per liter (mmol/L) | Standard Deviation 0.308 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Potassium | 4.19 millimoles per liter (mmol/L) | Standard Deviation 0.278 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 7 [Period 3]), Glucose | 4.72 millimoles per liter (mmol/L) | Standard Deviation 0.368 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 4 [Period 2]), Potassium | 4.29 millimoles per liter (mmol/L) | Standard Deviation 0.209 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 15 minutes (Period 3), Glucose | 5.07 millimoles per liter (mmol/L) | Standard Deviation 0.948 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Potassium | 4.12 millimoles per liter (mmol/L) | Standard Deviation 0.256 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 30 minutes (Period 3), Glucose | 5.05 millimoles per liter (mmol/L) | Standard Deviation 0.715 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 15 minutes (Period 2), Potassium | 4.10 millimoles per liter (mmol/L) | Standard Deviation 0.321 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1 hour (Period 3), Glucose | 5.05 millimoles per liter (mmol/L) | Standard Deviation 0.425 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Potassium | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.244 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 1.5 hours (Period 3), Glucose | 5.02 millimoles per liter (mmol/L) | Standard Deviation 0.4 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 30 minutes (Period 2), Potassium | 4.38 millimoles per liter (mmol/L) | Standard Deviation 0.561 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Glucose | 4.68 millimoles per liter (mmol/L) | Standard Deviation 0.383 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Potassium | 4.26 millimoles per liter (mmol/L) | Standard Deviation 0.193 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Glucose | 4.57 millimoles per liter (mmol/L) | Standard Deviation 0.315 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1 hour (Period 2), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.238 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Baseline (Pre-dose at Day 10 (Period 4), Glucose | 4.83 millimoles per liter (mmol/L) | Standard Deviation 0.286 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 2 hours (Period 3), Potassium | 4.28 millimoles per liter (mmol/L) | Standard Deviation 0.339 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 15 minutes (Period 4), Glucose | 5.23 millimoles per liter (mmol/L) | Standard Deviation 1.006 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 1.5 hours (Period 2), Potassium | 4.27 millimoles per liter (mmol/L) | Standard Deviation 0.371 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 30 minutes (Period 4), Glucose | 4.91 millimoles per liter (mmol/L) | Standard Deviation 0.692 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.134 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1 hour (Period 4), Glucose | 4.79 millimoles per liter (mmol/L) | Standard Deviation 0.512 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 2 hours (Period 2), Potassium | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.206 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 1.5 hours (Period 4), Glucose | 4.73 millimoles per liter (mmol/L) | Standard Deviation 0.368 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 7: Post-dose at 4 hours (Period 3), Potassium | 4.20 millimoles per liter (mmol/L) | Standard Deviation 0.183 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 2 hours (Period 4), Glucose | 4.66 millimoles per liter (mmol/L) | Standard Deviation 0.316 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 4: Post-dose at 4 hours (Period 2), Potassium | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.241 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium | Day 10: Post-dose at 4 hours (Period 4), Glucose | 4.68 millimoles per liter (mmol/L) | Standard Deviation 0.235 |
Secondary
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Calcium | 2.422 millimoles per liter (mmol/L) | Standard Deviation 0.1248 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Calcium | 2.313 millimoles per liter (mmol/L) | Standard Deviation 0.0598 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Sodium | 138.8 millimoles per liter (mmol/L) | Standard Deviation 1.69 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Sodium | 139.8 millimoles per liter (mmol/L) | Standard Deviation 1.77 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Urea Nitrogen | 4.33 millimoles per liter (mmol/L) | Standard Deviation 1.637 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Urea Nitrogen | 4.18 millimoles per liter (mmol/L) | Standard Deviation 0.877 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Urea Nitrogen | 5.39 millimoles per liter (mmol/L) | Standard Deviation 0.998 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Calcium | 2.388 millimoles per liter (mmol/L) | Standard Deviation 0.0683 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Sodium | 140.4 millimoles per liter (mmol/L) | Standard Deviation 1.55 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Calcium | 2.341 millimoles per liter (mmol/L) | Standard Deviation 0.1008 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Day 11 (Discharge), Urea Nitrogen | 4.38 millimoles per liter (mmol/L) | Standard Deviation 0.913 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen | Baseline (Day -1), Sodium | 139.1 millimoles per liter (mmol/L) | Standard Deviation 2.35 |
Secondary
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), ALP | 59.8 International Units per Liter (IU/L) | Standard Deviation 12.94 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), AST | 11.13 International Units per Liter (IU/L) | Standard Deviation 3.261 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), AST | 10.12 International Units per Liter (IU/L) | Standard Deviation 2.481 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), CPK | 87.8 International Units per Liter (IU/L) | Standard Deviation 47.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), CPK | 60.9 International Units per Liter (IU/L) | Standard Deviation 22.91 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), ALT | 19.15 International Units per Liter (IU/L) | Standard Deviation 10.383 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), ALT | 21.22 International Units per Liter (IU/L) | Standard Deviation 9.945 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), ALP | 64.1 International Units per Liter (IU/L) | Standard Deviation 14.94 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), ALP | 62.6 International Units per Liter (IU/L) | Standard Deviation 22.4 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), ALP | 60.1 International Units per Liter (IU/L) | Standard Deviation 20.92 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), CPK | 90.0 International Units per Liter (IU/L) | Standard Deviation 34.09 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), AST | 14.62 International Units per Liter (IU/L) | Standard Deviation 7.533 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), ALT | 25.63 International Units per Liter (IU/L) | Standard Deviation 18.822 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Day 11 (Discharge), AST | 13.72 International Units per Liter (IU/L) | Standard Deviation 13.046 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), ALT | 23.88 International Units per Liter (IU/L) | Standard Deviation 11.661 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) | Baseline (Day -1), CPK | 152.8 International Units per Liter (IU/L) | Standard Deviation 72.5 |
Secondary
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Creatinine | 64.8 micromoles per liter (umol/L) | Standard Deviation 12.69 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Total Protein | 68.0 micromoles per liter (umol/L) | Standard Deviation 3.14 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Direct Bilirubin | 3.58 micromoles per liter (umol/L) | Standard Deviation 2.523 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Total Bilirubin | 16.7 micromoles per liter (umol/L) | Standard Deviation 16.45 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Total Bilirubin | 11.8 micromoles per liter (umol/L) | Standard Deviation 8.65 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Total Protein | 74.8 micromoles per liter (umol/L) | Standard Deviation 2.41 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Creatinine | 61.6 micromoles per liter (umol/L) | Standard Deviation 12.91 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Direct Bilirubin | 3.75 micromoles per liter (umol/L) | Standard Deviation 2.021 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Creatinine | 71.9 micromoles per liter (umol/L) | Standard Deviation 12.3 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Total Bilirubin | 13.9 micromoles per liter (umol/L) | Standard Deviation 8.43 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Total Protein | 68.6 micromoles per liter (umol/L) | Standard Deviation 4.38 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Direct Bilirubin | 4.68 micromoles per liter (umol/L) | Standard Deviation 2.537 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Creatinine | 71.4 micromoles per liter (umol/L) | Standard Deviation 12.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Day 11 (Discharge), Direct Bilirubin | 4.18 micromoles per liter (umol/L) | Standard Deviation 2.461 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Total Protein | 71.8 micromoles per liter (umol/L) | Standard Deviation 3.69 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine | Baseline (Day -1), Total Bilirubin | 16.1 micromoles per liter (umol/L) | Standard Deviation 9.16 |
Secondary
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes | Day 11 (Discharge) | 4.575 Trillion cells/Liter | Standard Deviation 0.5669 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) | 5.028 Trillion cells/Liter | Standard Deviation 0.6223 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day -1) | 5.038 Trillion cells/Liter | Standard Deviation 0.4072 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes | Day 11 (Discharge) | 4.826 Trillion cells/Liter | Standard Deviation 0.4039 |
Secondary
Cohort 2: Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) | 0.450 Percentage of red blood cells in blood | Standard Deviation 0.0537 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Hematocrit | Day 11 (Discharge) | 0.412 Percentage of red blood cells in blood | Standard Deviation 0.0487 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day -1) | 0.458 Percentage of red blood cells in blood | Standard Deviation 0.0338 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Hematocrit | Day 11 (Discharge) | 0.440 Percentage of red blood cells in blood | Standard Deviation 0.0344 |
Secondary
Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) | 148.25 gram per liter (g/L) | Standard Deviation 18.566 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin | Day 11 (Discharge) | 134.99 gram per liter (g/L) | Standard Deviation 16.59 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day -1) | 149.95 gram per liter (g/L) | Standard Deviation 11.278 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin | Day 11 (Discharge) | 143.73 gram per liter (g/L) | Standard Deviation 12.17 |
Secondary
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) | 1.834 femtomole (fmol) | Standard Deviation 0.0868 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Day 11 (Discharge) | 1.837 femtomole (fmol) | Standard Deviation 0.098 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day -1) | 1.851 femtomole (fmol) | Standard Deviation 0.0808 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Day 11 (Discharge) | 1.853 femtomole (fmol) | Standard Deviation 0.0919 |
Secondary
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) | 89.8 femtoliter (fL) | Standard Deviation 4.1 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Day 11 (Discharge) | 90.3 femtoliter (fL) | Standard Deviation 3.99 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day -1) | 91.3 femtoliter (fL) | Standard Deviation 4.51 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Day 11 (Discharge) | 91.4 femtoliter (fL) | Standard Deviation 4.21 |
Secondary
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Population: Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Baseline (Day -1) | 0.03 Giga cells/Liter | Standard Deviation 0.048 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Day 11 (Discharge) | 0.00 Giga cells/Liter | Standard Deviation 0 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Baseline (Day -1) | 276.1 Giga cells/Liter | Standard Deviation 49.55 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Day 11 (Discharge) | 280.5 Giga cells/Liter | Standard Deviation 67.17 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Baseline (Day -1) | 4.56 Giga cells/Liter | Standard Deviation 1.563 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Day 11 (Discharge) | 4.20 Giga cells/Liter | Standard Deviation 1.344 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Baseline (Day -1) | 2.17 Giga cells/Liter | Standard Deviation 0.397 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Day 11 (Discharge) | 2.05 Giga cells/Liter | Standard Deviation 0.431 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Baseline (Day -1) | 0.35 Giga cells/Liter | Standard Deviation 0.113 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Day 11 (Discharge) | 0.34 Giga cells/Liter | Standard Deviation 0.096 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Baseline (Day -1) | 0.12 Giga cells/Liter | Standard Deviation 0.044 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Day 11 (Discharge) | 0.15 Giga cells/Liter | Standard Deviation 0.052 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Baseline (Day -1) | 0.13 Giga cells/Liter | Standard Deviation 0.06 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Baseline (Day -1) | 0.02 Giga cells/Liter | Standard Deviation 0.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Baseline (Day -1) | 2.01 Giga cells/Liter | Standard Deviation 0.359 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Basophils: Day 11 (Discharge) | 0.01 Giga cells/Liter | Standard Deviation 0.025 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Day 11 (Discharge) | 0.33 Giga cells/Liter | Standard Deviation 0.095 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Baseline (Day -1) | 219.3 Giga cells/Liter | Standard Deviation 46.78 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Lymphocytes: Day 11 (Discharge) | 1.98 Giga cells/Liter | Standard Deviation 0.34 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Platelet count: Day 11 (Discharge) | 221.3 Giga cells/Liter | Standard Deviation 53.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Eosinophils: Day 11 (Discharge) | 0.16 Giga cells/Liter | Standard Deviation 0.15 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Baseline (Day -1) | 3.11 Giga cells/Liter | Standard Deviation 0.559 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Monocytes: Baseline (Day -1) | 0.34 Giga cells/Liter | Standard Deviation 0.089 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count | Neutrophils: Day 11 (Discharge) | 2.81 Giga cells/Liter | Standard Deviation 0.521 |
Secondary
Cohort 2: Absolute Values of Pulse Rate (PR)
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 30 minutes (Period 1) | 75.8 Beats per minute | Standard Deviation 14.89 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 15 minutes (Period 3) | 68.8 Beats per minute | Standard Deviation 7.93 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 15 minutes (Period 2) | 67.1 Beats per minute | Standard Deviation 7.22 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 30 minutes (Period 3) | 67.4 Beats per minute | Standard Deviation 8.37 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 2 hours (Period 1) | 69.8 Beats per minute | Standard Deviation 13.26 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 1 hour (Period 3) | 65.7 Beats per minute | Standard Deviation 7.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 30 minutes (Period 2) | 64.8 Beats per minute | Standard Deviation 8.12 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 2 hours (Period 3) | 60.9 Beats per minute | Standard Deviation 6.53 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 15 minutes (Period 1) | 75.8 Beats per minute | Standard Deviation 13.49 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 4 hours (Period 3) | 56.9 Beats per minute | Standard Deviation 8.19 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 1 hour (Period 2) | 64.3 Beats per minute | Standard Deviation 8.27 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 10 (Period 4) | 65.5 Beats per minute | Standard Deviation 9.36 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 4 hours (Period 1) | 66.6 Beats per minute | Standard Deviation 14.31 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 15 minutes (Period 4) | 77.2 Beats per minute | Standard Deviation 11.63 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 2 hours (Period 2) | 60.0 Beats per minute | Standard Deviation 6.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 30 minutes (Period 4) | 77.2 Beats per minute | Standard Deviation 11.18 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 1 hour (Period 1) | 73.0 Beats per minute | Standard Deviation 18.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 1 hour (Period 4) | 74.4 Beats per minute | Standard Deviation 10.42 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 4 hours (Period 2) | 57.3 Beats per minute | Standard Deviation 7.5 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 2 hours (Period 4) | 70.2 Beats per minute | Standard Deviation 10.16 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 4 [Period 2]) | 56.4 Beats per minute | Standard Deviation 5.9 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 4 hours (Period 4) | 67.8 Beats per minute | Standard Deviation 10.21 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 7 [Period 3]) | 54.9 Beats per minute | Standard Deviation 8.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 1 [Period 1]) | 62.1 Beats per minute | Standard Deviation 11.55 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 1 hour (Period 3) | 72.9 Beats per minute | Standard Deviation 11.34 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 15 minutes (Period 1) | 67.7 Beats per minute | Standard Deviation 8.24 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 30 minutes (Period 1) | 64.0 Beats per minute | Standard Deviation 9.15 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 1 hour (Period 1) | 61.1 Beats per minute | Standard Deviation 8.3 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 2 hours (Period 1) | 57.4 Beats per minute | Standard Deviation 8.33 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 1: Post-dose at 4 hours (Period 1) | 56.4 Beats per minute | Standard Deviation 8.38 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 4 [Period 2]) | 62.1 Beats per minute | Standard Deviation 10.92 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 15 minutes (Period 2) | 77.6 Beats per minute | Standard Deviation 14.54 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 30 minutes (Period 2) | 74.8 Beats per minute | Standard Deviation 14.48 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 1 hour (Period 2) | 72.9 Beats per minute | Standard Deviation 11.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 2 hours (Period 2) | 67.1 Beats per minute | Standard Deviation 11.27 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 4: Post-dose at 4 hours (Period 2) | 63.9 Beats per minute | Standard Deviation 9.84 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 7 [Period 3]) | 64.3 Beats per minute | Standard Deviation 11.12 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 15 minutes (Period 3) | 74.2 Beats per minute | Standard Deviation 11.67 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 30 minutes (Period 3) | 73.8 Beats per minute | Standard Deviation 11.78 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 1 [Period 1]) | 51.3 Beats per minute | Standard Deviation 8.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 2 hours (Period 3) | 67.6 Beats per minute | Standard Deviation 10.22 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 7: Post-dose at 4 hours (Period 3) | 67.1 Beats per minute | Standard Deviation 11.54 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Baseline (Pre-dose at Day 10 (Period 4) | 54.0 Beats per minute | Standard Deviation 7.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 15 minutes (Period 4) | 69.3 Beats per minute | Standard Deviation 10 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 30 minutes (Period 4) | 67.9 Beats per minute | Standard Deviation 9.96 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 1 hour (Period 4) | 66.4 Beats per minute | Standard Deviation 8.71 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 2 hours (Period 4) | 61.4 Beats per minute | Standard Deviation 7.71 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Pulse Rate (PR) | Day 10: Post-dose at 4 hours (Period 4) | 58.3 Beats per minute | Standard Deviation 6.93 |
Secondary
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), SBP | 114.6 millimeters of mercury(mmHg) | Standard Deviation 9.5 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), SBP | 108.8 millimeters of mercury(mmHg) | Standard Deviation 7.06 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), DBP | 62.7 millimeters of mercury(mmHg) | Standard Deviation 3.48 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), SBP | 113.5 millimeters of mercury(mmHg) | Standard Deviation 12.44 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), SBP | 110.4 millimeters of mercury(mmHg) | Standard Deviation 8.25 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), SBP | 110.8 millimeters of mercury(mmHg) | Standard Deviation 8.47 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), DBP | 65.8 millimeters of mercury(mmHg) | Standard Deviation 5.3 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), SBP | 110.1 millimeters of mercury(mmHg) | Standard Deviation 11.02 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), SBP | 106.9 millimeters of mercury(mmHg) | Standard Deviation 8.09 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), DBP | 68.9 millimeters of mercury(mmHg) | Standard Deviation 7 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), DBP | 62.9 millimeters of mercury(mmHg) | Standard Deviation 3.92 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), DBP | 66.2 millimeters of mercury(mmHg) | Standard Deviation 7.29 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), SBP | 109.4 millimeters of mercury(mmHg) | Standard Deviation 7.37 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), DBP | 69.1 millimeters of mercury(mmHg) | Standard Deviation 6.74 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), DBP | 61.8 millimeters of mercury(mmHg) | Standard Deviation 7.11 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), DBP | 69.4 millimeters of mercury(mmHg) | Standard Deviation 7.27 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), DBP | 64.4 millimeters of mercury(mmHg) | Standard Deviation 4.73 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), DBP | 67.4 millimeters of mercury(mmHg) | Standard Deviation 6.58 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), SBP | 111.3 millimeters of mercury(mmHg) | Standard Deviation 11.47 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), DBP | 67.3 millimeters of mercury(mmHg) | Standard Deviation 6.26 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), DBP | 63.0 millimeters of mercury(mmHg) | Standard Deviation 4.26 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), DBP | 67.0 millimeters of mercury(mmHg) | Standard Deviation 6.92 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), SBP | 106.9 millimeters of mercury(mmHg) | Standard Deviation 10.16 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), SBP | 110.9 millimeters of mercury(mmHg) | Standard Deviation 9.21 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), SBP | 111.7 millimeters of mercury(mmHg) | Standard Deviation 10.44 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), DBP | 67.8 millimeters of mercury(mmHg) | Standard Deviation 7.78 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), SBP | 112.8 millimeters of mercury(mmHg) | Standard Deviation 10.05 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), SBP | 105.8 millimeters of mercury(mmHg) | Standard Deviation 7.3 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), SBP | 110.4 millimeters of mercury(mmHg) | Standard Deviation 9.05 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), SBP | 105.3 millimeters of mercury(mmHg) | Standard Deviation 9.7 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), DBP | 63.1 millimeters of mercury(mmHg) | Standard Deviation 5.44 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), SBP | 106.5 millimeters of mercury(mmHg) | Standard Deviation 9.9 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), SBP | 108.8 millimeters of mercury(mmHg) | Standard Deviation 9.64 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), DBP | 64.1 millimeters of mercury(mmHg) | Standard Deviation 6.56 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), SBP | 109.9 millimeters of mercury(mmHg) | Standard Deviation 8.61 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), DBP | 61.4 millimeters of mercury(mmHg) | Standard Deviation 5.33 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), SBP | 109.9 millimeters of mercury(mmHg) | Standard Deviation 8.04 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), DBP | 60.9 millimeters of mercury(mmHg) | Standard Deviation 4.53 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), DBP | 63.0 millimeters of mercury(mmHg) | Standard Deviation 4.58 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), DBP | 67.6 millimeters of mercury(mmHg) | Standard Deviation 6.76 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), SBP | 112.9 millimeters of mercury(mmHg) | Standard Deviation 12.96 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), SBP | 114.9 millimeters of mercury(mmHg) | Standard Deviation 12.04 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), DBP | 66.8 millimeters of mercury(mmHg) | Standard Deviation 7.83 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), SBP | 107.8 millimeters of mercury(mmHg) | Standard Deviation 8.63 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), DBP | 66.2 millimeters of mercury(mmHg) | Standard Deviation 6.62 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), DBP | 61.4 millimeters of mercury(mmHg) | Standard Deviation 4.3 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), DBP | 66.0 millimeters of mercury(mmHg) | Standard Deviation 7.97 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), SBP | 109.4 millimeters of mercury(mmHg) | Standard Deviation 7.44 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), DBP | 61.1 millimeters of mercury(mmHg) | Standard Deviation 4.4 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), DBP | 67.9 millimeters of mercury(mmHg) | Standard Deviation 8.11 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), DBP | 68.5 millimeters of mercury(mmHg) | Standard Deviation 7.45 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), DBP | 70.6 millimeters of mercury(mmHg) | Standard Deviation 7.83 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), DBP | 67.5 millimeters of mercury(mmHg) | Standard Deviation 7.01 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), DBP | 66.6 millimeters of mercury(mmHg) | Standard Deviation 6.5 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), DBP | 65.8 millimeters of mercury(mmHg) | Standard Deviation 7.96 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), DBP | 67.0 millimeters of mercury(mmHg) | Standard Deviation 5.12 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), DBP | 68.5 millimeters of mercury(mmHg) | Standard Deviation 7.48 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), DBP | 62.2 millimeters of mercury(mmHg) | Standard Deviation 6.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), SBP | 108.3 millimeters of mercury(mmHg) | Standard Deviation 6.78 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), SBP | 113.8 millimeters of mercury(mmHg) | Standard Deviation 9.52 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), SBP | 113.8 millimeters of mercury(mmHg) | Standard Deviation 8.71 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), SBP | 110.8 millimeters of mercury(mmHg) | Standard Deviation 9.66 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), SBP | 110.4 millimeters of mercury(mmHg) | Standard Deviation 11.43 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), SBP | 109.1 millimeters of mercury(mmHg) | Standard Deviation 7.05 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), SBP | 115.2 millimeters of mercury(mmHg) | Standard Deviation 11.87 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), SBP | 116.4 millimeters of mercury(mmHg) | Standard Deviation 11.17 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 1 hour (Period 2), SBP | 110.6 millimeters of mercury(mmHg) | Standard Deviation 9.87 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), SBP | 105.4 millimeters of mercury(mmHg) | Standard Deviation 7.95 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 4 hours (Period 2), SBP | 109.2 millimeters of mercury(mmHg) | Standard Deviation 10.94 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 7 [Period 3]), SBP | 107.5 millimeters of mercury(mmHg) | Standard Deviation 8.03 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 1 hour (Period 3), SBP | 108.4 millimeters of mercury(mmHg) | Standard Deviation 9.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 2 hours (Period 3), SBP | 105.7 millimeters of mercury(mmHg) | Standard Deviation 7.9 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 4 hours (Period 3), SBP | 108.8 millimeters of mercury(mmHg) | Standard Deviation 8.04 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), SBP | 108.4 millimeters of mercury(mmHg) | Standard Deviation 10.2 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 15 minutes (Period 4), SBP | 113.9 millimeters of mercury(mmHg) | Standard Deviation 12.37 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), SBP | 112.9 millimeters of mercury(mmHg) | Standard Deviation 11.75 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), SBP | 111.6 millimeters of mercury(mmHg) | Standard Deviation 10.18 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 1 [Period 1]), DBP | 64.9 millimeters of mercury(mmHg) | Standard Deviation 3.59 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 15 minutes (Period 1), DBP | 62.6 millimeters of mercury(mmHg) | Standard Deviation 5.24 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 30 minutes (Period 1), DBP | 63.2 millimeters of mercury(mmHg) | Standard Deviation 3.82 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 1 hour (Period 1), DBP | 61.5 millimeters of mercury(mmHg) | Standard Deviation 5.18 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 2 hours (Period 1), DBP | 62.5 millimeters of mercury(mmHg) | Standard Deviation 5.25 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1: Post-dose at 4 hours (Period 1), DBP | 64.6 millimeters of mercury(mmHg) | Standard Deviation 5.78 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), SBP | 106.6 millimeters of mercury(mmHg) | Standard Deviation 8.2 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 15 minutes (Period 3), SBP | 112.8 millimeters of mercury(mmHg) | Standard Deviation 9.89 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7: Post-dose at 30 minutes (Period 3), SBP | 114.1 millimeters of mercury(mmHg) | Standard Deviation 8.71 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), SBP | 108.4 millimeters of mercury(mmHg) | Standard Deviation 8.34 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 4 hours (Period 4), SBP | 108.6 millimeters of mercury(mmHg) | Standard Deviation 8.02 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 4 [Period 2]), DBP | 70.1 millimeters of mercury(mmHg) | Standard Deviation 7.09 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 30 minutes (Period 2), DBP | 68.9 millimeters of mercury(mmHg) | Standard Deviation 8.53 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 2 hours (Period 2), DBP | 66.9 millimeters of mercury(mmHg) | Standard Deviation 5.88 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose at Day 10 (Period 4), DBP | 64.9 millimeters of mercury(mmHg) | Standard Deviation 4.94 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 30 minutes (Period 4), DBP | 61.1 millimeters of mercury(mmHg) | Standard Deviation 6.77 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 1 hour (Period 4), DBP | 62.8 millimeters of mercury(mmHg) | Standard Deviation 5.21 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10: Post-dose at 2 hours (Period 4), DBP | 62.5 millimeters of mercury(mmHg) | Standard Deviation 5.3 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4: Post-dose at 15 minutes (Period 2), DBP | 66.5 millimeters of mercury(mmHg) | Standard Deviation 7.91 |
Secondary
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 1 | 8.56 Hour | Standard Deviation 1.945 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 4 | 7.65 Hour | Standard Deviation 1.022 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 7 | 7.61 Hour | Standard Deviation 1.247 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 10 | 7.87 Hour | Standard Deviation 1.678 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 10 | 7.74 Hour | Standard Deviation 1.613 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 1 | 7.73 Hour | Standard Deviation 1.162 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 7 | 7.57 Hour | Standard Deviation 1.438 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Apparent Terminal Phase Half-life (t1/2) | Day 4 | 7.79 Hour | Standard Deviation 1.38 |
Secondary
Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | 15345.11 h*pg/mL |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) | 12840.80 h*pg/mL |
Secondary
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 12.2 Beats per minute | Standard Deviation 4.99 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | 12.9 Beats per minute | Standard Deviation 7.17 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 11.6 Beats per minute | Standard Deviation 4.52 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Day 11 (Discharge) | 3.7 Beats per minute | Standard Deviation 5.21 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | 12.0 Beats per minute | Standard Deviation 8.45 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Day 11 (Discharge) | 4.0 Beats per minute | Standard Deviation 4.81 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | 13.2 Beats per minute | Standard Deviation 4.51 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 15.0 Beats per minute | Standard Deviation 9.1 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 11.1 Beats per minute | Standard Deviation 4.51 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | 13.0 Beats per minute | Standard Deviation 6.31 |
Secondary
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.
Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Population: Safety Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Day 11 (Discharge) | -5.9 milliseconds | Standard Deviation 9.4 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | -7.0 milliseconds | Standard Deviation 6.96 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 0.7 milliseconds | Standard Deviation 9.87 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 2.6 milliseconds | Standard Deviation 11.18 |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | -1.7 milliseconds | Standard Deviation 5.52 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Day 11 (Discharge) | -6.5 milliseconds | Standard Deviation 8.79 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 7 [Period 3] | 5.1 milliseconds | Standard Deviation 16.88 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 1 [Period 1] | 3.0 milliseconds | Standard Deviation 10.59 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 10 [Period 4] | 2.9 milliseconds | Standard Deviation 8.88 |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals | CFB to Post-dose at 30 minutes on Day 4 [Period 2] | 0.0 milliseconds | Standard Deviation 14.23 |
Secondary
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Population: Safety Population included all participants who received at least one puff/actuation of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 20 Participants |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 21 Participants |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
Secondary
Cohort 2-Intra-Participant Variability of AUC (0-30min)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2-Intra-Participant Variability of AUC (0-30min) | 22.9 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2-Intra-Participant Variability of AUC (0-30min) | 25.8 Percentage of Coefficient Variation |
Secondary
Cohort 2: Intra Participant Variability of AUC (0-infinity)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Intra Participant Variability of AUC (0-infinity) | 10.0 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Intra Participant Variability of AUC (0-infinity) | 8.6 Percentage of Coefficient Variation |
Secondary
Cohort 2: Intra Participant Variability of AUC (0-last)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Intra Participant Variability of AUC (0-last) | 10.4 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Intra Participant Variability of AUC (0-last) | 9.0 Percentage of Coefficient Variation |
Secondary
Cohort 2: Intra Participant Variability of Cmax
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Population: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Intra Participant Variability of Cmax | 14.1 Percentage of Coefficient Variation |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Intra Participant Variability of Cmax | 12.2 Percentage of Coefficient Variation |
Secondary
Cohort 2: Time to Reach Cmax (Tmax)
Blood samples were collected for the analysis of PK parameters.
Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4]
Population: Pharmacokinetic Population. Overall Number of Participants Analyzed included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Time to Reach Cmax (Tmax) | Day 1 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Time to Reach Cmax (Tmax) | Day 4 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Time to Reach Cmax (Tmax) | Day 7 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) | Cohort 2: Time to Reach Cmax (Tmax) | Day 10 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Time to Reach Cmax (Tmax) | Day 10 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Time to Reach Cmax (Tmax) | Day 1 | 1.25 Hour |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Time to Reach Cmax (Tmax) | Day 7 | 1.50 Hour |
| Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) | Cohort 2: Time to Reach Cmax (Tmax) | Day 4 | 1.50 Hour |