Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

A Single Dose Two-way Cross-over Study in Healthy Participants to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a and HFA-134a

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05791565

Enrollment

Registered

2023-03-30

Start date

2023-04-03

Completion date

2023-05-21

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Cross-over, Healthy volunteers, Salbutamol, Pharmacokinetics

Brief summary

This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.

Interventions

DRUGSalbutamol HFA-152a

Salbutamol HFA-152a will be administered.

DRUGSalbutamol HFA-134a

Salbutamol HFA-134a will be administered.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

This will be a double-blind study.

Intervention model description

This is a 2-way cross-over study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Aged 18 to 55 years, inclusive, at screening * Body mass index 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, at screening * Weight: greater than or equal to (\>=)50 kg * At screening, females must not be pregnant or lactating, or of non-childbearing potential * Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception * Male participants, if not surgically sterilized, must agree to use adequate contraception * Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator * Willing and able to sign the informed consent form

Exclusion criteria

* 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; constituting a risk when taking the study intervention or interfering with the interpretation of data * History or presence of any form of asthma, including childhood asthma and exercise induced asthma * Current enrollment or past participation in this clinical study * Participants with clinically significant abnormalities * A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse * Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission * Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator

Design outcomes

Primary

Measure	Time frame	Description
AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol	Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol	Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of Salbutamol	Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol	Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Secondary

Measure	Time frame	Description
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count.
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV).
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH).
Absolute Values of Hematology Parameter: Hemoglobin	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Hemoglobin.
Absolute Values of Hematology Parameter: Hematocrit	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Hematocrit.
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK).
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine.
Absolute Values of Clinical Chemistry Parameter: Total Protein	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Total protein.
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	On Day -1 (admission) and Day 5 (Discharge)	Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen.
Absolute Values for Chemistry Parameter: Glucose	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	Blood samples were collected for analyzing absolute values of glucose.
Number of Participants With Urinalysis Parameters by Dipstick Method	On Day -1 (admission) and Day 5 (Discharge)	Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'.
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	Blood pressure 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.
Absolute Values of Pulse Rate	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 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.
Time to Cmax (Tmax) of Salbutamol	Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Apparent Terminal Phase Half-life (t1/2) of Salbutamol	Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4	Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol	0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Minimum observed concentration of potassium levels after dose are presented.
Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)	Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval.
Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol	0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Maximum observed heart rate (HR) after dose is presented.
Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)	Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval.
Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol	0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Maximum observed QTcF after dose are presented.
Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)	Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)	Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: \[(C2+C1)/2×(t2-t1)\]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval.
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 5 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Absolute Values of ECG Parameter: Heart Rate	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Change From Baseline in ECG Parameters: Heart Rate	Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4	A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.

Countries

Netherlands

Participant flow

Participants by arm

Arm	Count
Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.	14
Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period.	14
Total	28

Withdrawals & dropouts

Period	Reason	FG000	FG001
Washout Period (Minimum 72 Hours)	Adverse Event	1	0

Baseline characteristics

Characteristic	Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI	Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI	Total
Age, Continuous	31.4 Years STANDARD_DEVIATION 11.03	31.5 Years STANDARD_DEVIATION 11.59	31.5 Years STANDARD_DEVIATION 11.1
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants	14 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	9 Participants	5 Participants	14 Participants
Sex: Female, Male Male	5 Participants	9 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 27
other Total, other adverse events	6 / 28	8 / 27
serious Total, serious adverse events	0 / 28	0 / 27

Outcome results

Primary

Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4

Population: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol	0.622 Hournanogram/milliliter (hng/mL)
Salbutamol HFA-134a MDI	Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol	0.536 Hournanogram/milliliter (hng/mL)

90% CI: [1.0221, 1.3185]

Primary

AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol	21.1 Hournanogram/milliliter (hng/mL)
Salbutamol HFA-134a MDI	AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol	15.0 Hournanogram/milliliter (hng/mL)

90% CI: [1.2998, 1.5255]

Primary

AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol	19.0 Hournanogram/millilitre (hng/mL)
Salbutamol HFA-134a MDI	AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol	13.7 Hournanogram/millilitre (hng/mL)

90% CI: [1.2793, 1.507]

Primary

Maximum Observed Plasma Concentration (Cmax) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Maximum Observed Plasma Concentration (Cmax) of Salbutamol	2.36 nanogram/millilitre (ng/mL)
Salbutamol HFA-134a MDI	Maximum Observed Plasma Concentration (Cmax) of Salbutamol	1.80 nanogram/millilitre (ng/mL)

90% CI: [1.1816, 1.4614]

Secondary

Absolute Values for Chemistry Parameter: Glucose

Blood samples were collected for analyzing absolute values of glucose.

Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 30 min post-dose	5.64 Millimoles per liter	Standard Deviation 1.79
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Baseline (Day 1, Predose)	5.04 Millimoles per liter	Standard Deviation 0.599
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 15 min post-dose	5.43 Millimoles per liter	Standard Deviation 2.067
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 1 h post-dose	5.47 Millimoles per liter	Standard Deviation 1.221
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 1.5 h post-dose	5.44 Millimoles per liter	Standard Deviation 0.925
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 2 h post-dose	5.24 Millimoles per liter	Standard Deviation 0.626
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 4 h post-dose	4.74 Millimoles per liter	Standard Deviation 0.378
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Baseline (Day 4, Predose)	4.76 Millimoles per liter	Standard Deviation 0.29
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 15 min post-dose	5.06 Millimoles per liter	Standard Deviation 0.838
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 30 min post-dose	5.13 Millimoles per liter	Standard Deviation 0.637
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 1 h post-dose	5.15 Millimoles per liter	Standard Deviation 0.455
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 2 h post-dose	4.96 Millimoles per liter	Standard Deviation 0.262
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 4 h post-dose	4.71 Millimoles per liter	Standard Deviation 0.248
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 1.5 h post-dose	5.11 Millimoles per liter	Standard Deviation 0.296
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 1 h post-dose	5.33 Millimoles per liter	Standard Deviation 1.434
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Baseline (Day 4, Predose)	5.03 Millimoles per liter	Standard Deviation 0.964
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Baseline (Day 1, Predose)	4.89 Millimoles per liter	Standard Deviation 0.297
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 4 h post-dose	4.66 Millimoles per liter	Standard Deviation 0.38
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 15 min post-dose	5.02 Millimoles per liter	Standard Deviation 0.587
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 30 min post-dose	5.14 Millimoles per liter	Standard Deviation 0.482
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 15 min post-dose	5.24 Millimoles per liter	Standard Deviation 2.514
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 1 h post-dose	5.24 Millimoles per liter	Standard Deviation 0.533
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 2 h post-dose	5.11 Millimoles per liter	Standard Deviation 0.999
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 1.5 h post-dose	5.11 Millimoles per liter	Standard Deviation 0.369
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 30 min post-dose	5.34 Millimoles per liter	Standard Deviation 2.064
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 2 h post-dose	4.90 Millimoles per liter	Standard Deviation 0.335
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 4, 1.5 h post-dose	5.24 Millimoles per liter	Standard Deviation 1.171
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameter: Glucose	Day 1, 4 h post-dose	4.71 Millimoles per liter	Standard Deviation 0.348

Secondary

Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)

Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Calcium, Day -1	2.535 Millimoles per liter	Standard Deviation 0.0769
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Calcium, Day 5	2.466 Millimoles per liter	Standard Deviation 0.0756
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Sodium, Day -1	140.07 Millimoles per liter	Standard Deviation 0.829
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Sodium, Day 5	140.21 Millimoles per liter	Standard Deviation 1.188
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	BUN, Day -1	4.81 Millimoles per liter	Standard Deviation 0.903
Salbutamol HFA-152a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	BUN, Day 5	4.66 Millimoles per liter	Standard Deviation 1.203
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	BUN, Day -1	4.96 Millimoles per liter	Standard Deviation 1.709
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Calcium, Day -1	2.549 Millimoles per liter	Standard Deviation 0.0934
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Sodium, Day 5	139.69 Millimoles per liter	Standard Deviation 1.032
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Calcium, Day 5	2.442 Millimoles per liter	Standard Deviation 0.0893
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	BUN, Day 5	4.38 Millimoles per liter	Standard Deviation 0.791
Salbutamol HFA-134a MDI	Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)	Sodium, Day -1	139.43 Millimoles per liter	Standard Deviation 1.742

Secondary

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).

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALP, Day -1	69.57 International units per Liter	Standard Deviation 20.429
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	CPK, Day -1	141.50 International units per Liter	Standard Deviation 106.36
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	AST, Day -1	17.64 International units per Liter	Standard Deviation 10.725
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	CPK, Day 5	75.71 International units per Liter	Standard Deviation 34.003
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALP, Day 5	61.93 International units per Liter	Standard Deviation 18.898
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALT, Day -1	24.21 International units per Liter	Standard Deviation 13.634
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	AST, Day 5	16.29 International units per Liter	Standard Deviation 4.581
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALT, Day 5	26.36 International units per Liter	Standard Deviation 12.959
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	AST, Day 5	17.54 International units per Liter	Standard Deviation 11.23
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALP, Day -1	66.36 International units per Liter	Standard Deviation 19.262
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALP, Day 5	61.46 International units per Liter	Standard Deviation 20.206
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	AST, Day -1	15.29 International units per Liter	Standard Deviation 4.027
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALT, Day 5	24.38 International units per Liter	Standard Deviation 14.728
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	CPK, Day -1	121.36 International units per Liter	Standard Deviation 95.447
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	CPK, Day 5	62.38 International units per Liter	Standard Deviation 20.077
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)	ALT, Day -1	24.14 International units per Liter	Standard Deviation 11.481

Secondary

Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine

Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Direct Bilirubin, Day -1	2.86 Micromoles per liter	Standard Deviation 1.562
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Direct Bilirubin, Day 5	3.14 Micromoles per liter	Standard Deviation 0.949
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Total Bilirubin, Day -1	9.64 Micromoles per liter	Standard Deviation 3.954
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Total Bilirubin, Day 5	9.57 Micromoles per liter	Standard Deviation 2.709
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Creatinine, Day -1	63.36 Micromoles per liter	Standard Deviation 11.311
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Creatinine, Day 5	71.29 Micromoles per liter	Standard Deviation 12.363
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Creatinine, Day -1	69.57 Micromoles per liter	Standard Deviation 12.145
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Direct Bilirubin, Day -1	3.57 Micromoles per liter	Standard Deviation 1.158
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Total Bilirubin, Day 5	8.08 Micromoles per liter	Standard Deviation 2.397
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Direct Bilirubin, Day 5	2.46 Micromoles per liter	Standard Deviation 1.391
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Creatinine, Day 5	61.77 Micromoles per liter	Standard Deviation 9.427
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine	Total Bilirubin, Day -1	11.43 Micromoles per liter	Standard Deviation 3.877

Secondary

Absolute Values of Clinical Chemistry Parameter: Total Protein

Blood samples were collected for analyzing absolute values of Total protein.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameter: Total Protein	Day -1	75.21 Grams per liter	Standard Deviation 3.886
Salbutamol HFA-152a MDI	Absolute Values of Clinical Chemistry Parameter: Total Protein	Day 5	68.57 Grams per liter	Standard Deviation 3.106
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameter: Total Protein	Day -1	73.93 Grams per liter	Standard Deviation 3.149
Salbutamol HFA-134a MDI	Absolute Values of Clinical Chemistry Parameter: Total Protein	Day 5	68.00 Grams per liter	Standard Deviation 2.121

Secondary

Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Blood pressure 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 at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 15 min post-dose	118.2 Millimeters of mercury [mmHg]	Standard Deviation 9
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 15 min post-dose	67.4 Millimeters of mercury [mmHg]	Standard Deviation 7.59
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 30 min post-dose	121.6 Millimeters of mercury [mmHg]	Standard Deviation 15.05
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 1.5 h post-dose	65.3 Millimeters of mercury [mmHg]	Standard Deviation 5.98
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 1 h post-dose	114.9 Millimeters of mercury [mmHg]	Standard Deviation 9.14
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 30 min post-dose	67.0 Millimeters of mercury [mmHg]	Standard Deviation 6.23
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 1.5 h post-dose	110.1 Millimeters of mercury [mmHg]	Standard Deviation 8.27
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 15 min post-dose	68.2 Millimeters of mercury [mmHg]	Standard Deviation 6.42
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 2 h post-dose	111.5 Millimeters of mercury [mmHg]	Standard Deviation 8.54
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 2 h post-dose	66.3 Millimeters of mercury [mmHg]	Standard Deviation 4.18
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Baseline (Day 4, Predose)	114.8 Millimeters of mercury [mmHg]	Standard Deviation 8.31
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 1.5 h post-dose	67.4 Millimeters of mercury [mmHg]	Standard Deviation 6.48
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 15 min post-dose	119.1 Millimeters of mercury [mmHg]	Standard Deviation 9.68
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 1 h post-dose	67.8 Millimeters of mercury [mmHg]	Standard Deviation 7.16
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 30 min post-dose	119.8 Millimeters of mercury [mmHg]	Standard Deviation 10.96
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 2 h post-dose	67.9 Millimeters of mercury [mmHg]	Standard Deviation 7.71
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 1 h post-dose	115.2 Millimeters of mercury [mmHg]	Standard Deviation 8.74
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 4 h post-dose	68.1 Millimeters of mercury [mmHg]	Standard Deviation 6.44
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 1.5 h post-dose	115.9 Millimeters of mercury [mmHg]	Standard Deviation 12.07
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 4 h post-dose	68.5 Millimeters of mercury [mmHg]	Standard Deviation 6.31
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 2 h post-dose	115.9 Millimeters of mercury [mmHg]	Standard Deviation 11.84
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Baseline (Day 4, Predose)	72.1 Millimeters of mercury [mmHg]	Standard Deviation 6.64
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 4 h post-dose	113.6 Millimeters of mercury [mmHg]	Standard Deviation 11.04
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Baseline (Day 1, Predose)	111.9 Millimeters of mercury [mmHg]	Standard Deviation 8.49
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 30 min post-dose	70.6 Millimeters of mercury [mmHg]	Standard Deviation 9.3
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 1 h post-dose	68.5 Millimeters of mercury [mmHg]	Standard Deviation 7.86
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 4 h post-dose	112.5 Millimeters of mercury [mmHg]	Standard Deviation 8.84
Salbutamol HFA-152a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Baseline (Day 1, Predose)	69.1 Millimeters of mercury [mmHg]	Standard Deviation 6.27
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 4 h post-dose	112.0 Millimeters of mercury [mmHg]	Standard Deviation 10.91
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Baseline (Day 1, Predose)	69.4 Millimeters of mercury [mmHg]	Standard Deviation 7.21
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 15 min post-dose	67.8 Millimeters of mercury [mmHg]	Standard Deviation 7.82
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 30 min post-dose	69.1 Millimeters of mercury [mmHg]	Standard Deviation 9.21
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 1 h post-dose	67.4 Millimeters of mercury [mmHg]	Standard Deviation 8.78
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 1.5 h post-dose	67.8 Millimeters of mercury [mmHg]	Standard Deviation 8.46
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 2 h post-dose	66.1 Millimeters of mercury [mmHg]	Standard Deviation 8.23
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Baseline (Day 4, Predose)	67.9 Millimeters of mercury [mmHg]	Standard Deviation 5.51
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 15 min post-dose	64.9 Millimeters of mercury [mmHg]	Standard Deviation 4.33
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 30 min post-dose	63.8 Millimeters of mercury [mmHg]	Standard Deviation 4.44
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 1 h post-dose	65.4 Millimeters of mercury [mmHg]	Standard Deviation 3.69
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 1.5 h post-dose	63.6 Millimeters of mercury [mmHg]	Standard Deviation 5.17
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 2 h post-dose	64.1 Millimeters of mercury [mmHg]	Standard Deviation 5.78
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 4, 4 h post-dose	65.6 Millimeters of mercury [mmHg]	Standard Deviation 6.13
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Baseline (Day 1, Predose)	113.0 Millimeters of mercury [mmHg]	Standard Deviation 10.24
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 15 min post-dose	119.1 Millimeters of mercury [mmHg]	Standard Deviation 10.27
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 30 min post-dose	118.6 Millimeters of mercury [mmHg]	Standard Deviation 10.48
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 1 h post-dose	116.7 Millimeters of mercury [mmHg]	Standard Deviation 8.91
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 1.5 h post-dose	115.7 Millimeters of mercury [mmHg]	Standard Deviation 10.36
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 1, 2 h post-dose	112.9 Millimeters of mercury [mmHg]	Standard Deviation 10.57
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Baseline (Day 4, Predose)	108.6 Millimeters of mercury [mmHg]	Standard Deviation 7.15
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 15 min post-dose	116.1 Millimeters of mercury [mmHg]	Standard Deviation 9.72
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 30 min post-dose	112.5 Millimeters of mercury [mmHg]	Standard Deviation 7.87
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 1 h post-dose	111.6 Millimeters of mercury [mmHg]	Standard Deviation 11.15
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 1.5 h post-dose	109.2 Millimeters of mercury [mmHg]	Standard Deviation 7.61
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 2 h post-dose	108.2 Millimeters of mercury [mmHg]	Standard Deviation 10.6
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	SBP, Day 4, 4 h post-dose	108.9 Millimeters of mercury [mmHg]	Standard Deviation 9.18
Salbutamol HFA-134a MDI	Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	DBP, Day 1, 4 h post-dose	67.6 Millimeters of mercury [mmHg]	Standard Deviation 8.99

Secondary

Absolute Values of ECG Parameter: Heart Rate

A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.

Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Baseline (Day 1, Predose)	59.9 Beats per minute	Standard Deviation 10.01
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 15 min post-dose	71.6 Beats per minute	Standard Deviation 8.73
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 30 min post-dose	71.9 Beats per minute	Standard Deviation 9.98
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 1 h post-dose	67.4 Beats per minute	Standard Deviation 8.54
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 1.5 h post-dose	63.9 Beats per minute	Standard Deviation 6.2
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 2 h post-dose	61.5 Beats per minute	Standard Deviation 6.55
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 4 h post-dose	58.4 Beats per minute	Standard Deviation 7.32
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Baseline (Day 4, Predose)	61.1 Beats per minute	Standard Deviation 8.65
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 15 min post-dose	72.5 Beats per minute	Standard Deviation 7.14
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 30 min post-dose	72.1 Beats per minute	Standard Deviation 10.05
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 1 h post-dose	68.6 Beats per minute	Standard Deviation 9.74
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 1.5 h post-dose	65.9 Beats per minute	Standard Deviation 9.54
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 2 h post-dose	65.0 Beats per minute	Standard Deviation 7.84
Salbutamol HFA-152a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 4 h post-dose	62.7 Beats per minute	Standard Deviation 8.53
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 1 h post-dose	66.2 Beats per minute	Standard Deviation 7.8
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Baseline (Day 1, Predose)	63.2 Beats per minute	Standard Deviation 8.12
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Baseline (Day 4, Predose)	57.8 Beats per minute	Standard Deviation 9.53
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 15 min post-dose	73.3 Beats per minute	Standard Deviation 9.51
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 2 h post-dose	61.2 Beats per minute	Standard Deviation 7.84
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 30 min post-dose	70.5 Beats per minute	Standard Deviation 11.8
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 15 min post-dose	71.8 Beats per minute	Standard Deviation 11.16
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 1 h post-dose	67.9 Beats per minute	Standard Deviation 10.86
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 1.5 h post-dose	62.4 Beats per minute	Standard Deviation 8.43
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 1.5 h post-dose	67.9 Beats per minute	Standard Deviation 9.34
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 30 min post-dose	69.6 Beats per minute	Standard Deviation 9.89
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 2 h post-dose	63.1 Beats per minute	Standard Deviation 8.98
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 4, 4 h post-dose	57.1 Beats per minute	Standard Deviation 7.95
Salbutamol HFA-134a MDI	Absolute Values of ECG Parameter: Heart Rate	Day 1, 4 h post-dose	63.9 Beats per minute	Standard Deviation 9.38

Secondary

Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval

A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period.

Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Baseline (Day 1, Predose)	93.0 Milliseconds	Standard Deviation 9.27
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 15 min post-dose	149.2 Milliseconds	Standard Deviation 21.93
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 30 min post-dose	149.8 Milliseconds	Standard Deviation 23.13
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 1 h post-dose	151.6 Milliseconds	Standard Deviation 20.25
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 1.5 h post-dose	153.2 Milliseconds	Standard Deviation 22.04
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 2 h post-dose	156.2 Milliseconds	Standard Deviation 23.4
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 4 h post-dose	153.3 Milliseconds	Standard Deviation 24.82
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Baseline (Day 4, Predose)	157.6 Milliseconds	Standard Deviation 18.16
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 15 min post-dose	147.5 Milliseconds	Standard Deviation 17.17
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 30 min post-dose	151.4 Milliseconds	Standard Deviation 17.08
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 1 h post-dose	150.2 Milliseconds	Standard Deviation 15.34
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 1.5 h post-dose	153.6 Milliseconds	Standard Deviation 17.91
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 2 h post-dose	149.3 Milliseconds	Standard Deviation 18.03
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 4 h post-dose	152.3 Milliseconds	Standard Deviation 18.51
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Baseline (Day 1, Predose)	160.5 Milliseconds	Standard Deviation 25.47
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 15 min post-dose	92.0 Milliseconds	Standard Deviation 8.73
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 30 min post-dose	92.1 Milliseconds	Standard Deviation 9.68
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 1 h post-dose	91.5 Milliseconds	Standard Deviation 9.98
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 1.5 h post-dose	92.4 Milliseconds	Standard Deviation 8.87
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 2 h post-dose	92.1 Milliseconds	Standard Deviation 8.12
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 4 h post-dose	91.8 Milliseconds	Standard Deviation 7.95
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Baseline (Day 4, Predose)	97.9 Milliseconds	Standard Deviation 8.99
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 15 min post-dose	96.9 Milliseconds	Standard Deviation 9.56
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 30 min post-dose	97.6 Milliseconds	Standard Deviation 9.58
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 1 h post-dose	96.6 Milliseconds	Standard Deviation 9.04
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 1.5 h post-dose	96.2 Milliseconds	Standard Deviation 11.45
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 2 h post-dose	97.3 Milliseconds	Standard Deviation 8.92
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 4 h post-dose	96.3 Milliseconds	Standard Deviation 9.12
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Baseline (Day 1, Predose)	404.2 Milliseconds	Standard Deviation 27.19
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 15 min post-dose	374.9 Milliseconds	Standard Deviation 26.22
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 30 min post-dose	377.2 Milliseconds	Standard Deviation 27.45
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 1 h post-dose	386.7 Milliseconds	Standard Deviation 26.95
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 1.5 h post-dose	393.9 Milliseconds	Standard Deviation 24.8
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 2 h post-dose	399.4 Milliseconds	Standard Deviation 25.22
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 4 h post-dose	407.8 Milliseconds	Standard Deviation 27.67
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Baseline (Day 4, Predose)	400.8 Milliseconds	Standard Deviation 22.66
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 15 min post-dose	373.8 Milliseconds	Standard Deviation 18.52
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 30 min post-dose	379.0 Milliseconds	Standard Deviation 19.41
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 1 h post-dose	382.8 Milliseconds	Standard Deviation 20.18
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 1.5 h post-dose	386.7 Milliseconds	Standard Deviation 20.72
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 2 h post-dose	393.0 Milliseconds	Standard Deviation 20.55
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 4 h post-dose	397.0 Milliseconds	Standard Deviation 22.25
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Baseline (Day 1, Predose)	402.1 Milliseconds	Standard Deviation 15.47
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 15 min post-dose	396.9 Milliseconds	Standard Deviation 21.86
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 30 min post-dose	399.6 Milliseconds	Standard Deviation 19.47
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 1 h post-dose	400.6 Milliseconds	Standard Deviation 20.43
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 1.5 h post-dose	401.9 Milliseconds	Standard Deviation 18.11
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 2 h post-dose	402.4 Milliseconds	Standard Deviation 16.1
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 4 h post-dose	403.2 Milliseconds	Standard Deviation 19.19
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Baseline (Day 4, Predose)	402.2 Milliseconds	Standard Deviation 14.44
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 15 min post-dose	398.0 Milliseconds	Standard Deviation 15
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 30 min post-dose	402.0 Milliseconds	Standard Deviation 14.22
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 1 h post-dose	399.2 Milliseconds	Standard Deviation 17.52
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 1.5 h post-dose	397.9 Milliseconds	Standard Deviation 15.28
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 2 h post-dose	402.9 Milliseconds	Standard Deviation 16.16
Salbutamol HFA-152a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 4 h post-dose	402.1 Milliseconds	Standard Deviation 18.19
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 1 h post-dose	398.8 Milliseconds	Standard Deviation 17.62
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Baseline (Day 1, Predose)	157.1 Milliseconds	Standard Deviation 17.57
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Baseline (Day 1, Predose)	398.3 Milliseconds	Standard Deviation 19.86
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 15 min post-dose	150.2 Milliseconds	Standard Deviation 16.59
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Baseline (Day 1, Predose)	404.2 Milliseconds	Standard Deviation 14.33
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 30 min post-dose	153.2 Milliseconds	Standard Deviation 17.12
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 15 min post-dose	372.5 Milliseconds	Standard Deviation 18.15
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 1 h post-dose	151.4 Milliseconds	Standard Deviation 17.05
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Baseline (Day 4, Predose)	397.4 Milliseconds	Standard Deviation 16.3
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 1.5 h post-dose	154.6 Milliseconds	Standard Deviation 16.99
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 30 min post-dose	380.8 Milliseconds	Standard Deviation 21.76
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 2 h post-dose	153.5 Milliseconds	Standard Deviation 18.47
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 15 min post-dose	397.1 Milliseconds	Standard Deviation 12.97
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 1, 4 h post-dose	154.4 Milliseconds	Standard Deviation 16.4
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 1 h post-dose	384.1 Milliseconds	Standard Deviation 23.81
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Baseline (Day 4, Predose)	159.1 Milliseconds	Standard Deviation 24.95
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 2 h post-dose	397.8 Milliseconds	Standard Deviation 17.85
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 15 min post-dose	146.6 Milliseconds	Standard Deviation 22.61
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 1.5 h post-dose	385.3 Milliseconds	Standard Deviation 22.84
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 30 min post-dose	151.1 Milliseconds	Standard Deviation 25.81
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 30 min post-dose	400.1 Milliseconds	Standard Deviation 14.56
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 1 h post-dose	153.8 Milliseconds	Standard Deviation 24.73
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 2 h post-dose	391.2 Milliseconds	Standard Deviation 23.68
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 1.5 h post-dose	154.9 Milliseconds	Standard Deviation 21.45
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 15 min post-dose	396.3 Milliseconds	Standard Deviation 18.45
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 2 h post-dose	153.4 Milliseconds	Standard Deviation 22.01
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 1, 4 h post-dose	395.7 Milliseconds	Standard Deviation 23.27
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	PR, Day 4, 4 h post-dose	157.7 Milliseconds	Standard Deviation 25.82
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 1 h post-dose	398.9 Milliseconds	Standard Deviation 14.45
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Baseline (Day 1, Predose)	98.5 Milliseconds	Standard Deviation 9.18
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Baseline (Day 4, Predose)	403.5 Milliseconds	Standard Deviation 25.28
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 15 min post-dose	98.8 Milliseconds	Standard Deviation 10.28
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 1.5 h post-dose	392.7 Milliseconds	Standard Deviation 19.45
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 30 min post-dose	97.6 Milliseconds	Standard Deviation 11.97
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 15 min post-dose	374.2 Milliseconds	Standard Deviation 22.98
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 1 h post-dose	97.6 Milliseconds	Standard Deviation 10.44
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 1.5 h post-dose	399.9 Milliseconds	Standard Deviation 12.09
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 1.5 h post-dose	97.0 Milliseconds	Standard Deviation 10.91
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 30 min post-dose	379.8 Milliseconds	Standard Deviation 22.75
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 2 h post-dose	99.4 Milliseconds	Standard Deviation 9.87
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 30 min post-dose	398.2 Milliseconds	Standard Deviation 23.29
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 1, 4 h post-dose	98.0 Milliseconds	Standard Deviation 8.82
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 1 h post-dose	386.2 Milliseconds	Standard Deviation 19.16
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Baseline (Day 4, Predose)	92.4 Milliseconds	Standard Deviation 7.78
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 2 h post-dose	396.8 Milliseconds	Standard Deviation 13.55
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 15 min post-dose	91.4 Milliseconds	Standard Deviation 7.41
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 1.5 h post-dose	388.5 Milliseconds	Standard Deviation 20.27
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 30 min post-dose	91.6 Milliseconds	Standard Deviation 8.28
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 4, 4 h post-dose	398.2 Milliseconds	Standard Deviation 16.22
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 1 h post-dose	92.2 Milliseconds	Standard Deviation 8.51
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 2 h post-dose	395.5 Milliseconds	Standard Deviation 18.59
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 1.5 h post-dose	92.6 Milliseconds	Standard Deviation 7.02
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QTc interval, Day 1, 4 h post-dose	403.1 Milliseconds	Standard Deviation 13.57
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 2 h post-dose	93.2 Milliseconds	Standard Deviation 7.96
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QT interval, Day 4, 4 h post-dose	405.4 Milliseconds	Standard Deviation 22.9
Salbutamol HFA-134a MDI	Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval	QRS duration, Day 4, 4 h post-dose	90.2 Milliseconds	Standard Deviation 8.12

Secondary

Absolute Values of Hematology Parameter: Hematocrit

Blood samples were collected for analyzing absolute values of Hematocrit.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Hematocrit	Day -1	0.416 Percentage	Standard Deviation 0.0352
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Hematocrit	Day 5	0.404 Percentage	Standard Deviation 0.033
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Hematocrit	Day -1	0.436 Percentage	Standard Deviation 0.0313
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Hematocrit	Day 5	0.392 Percentage	Standard Deviation 0.0302

Secondary

Absolute Values of Hematology Parameter: Hemoglobin

Blood samples were collected for analyzing absolute values of Hemoglobin.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Hemoglobin	Day -1	143.87 Grams per Liter	Standard Deviation 11.978
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Hemoglobin	Day 5	140.76 Grams per Liter	Standard Deviation 11.437
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Hemoglobin	Day -1	150.79 Grams per Liter	Standard Deviation 11.125
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Hemoglobin	Day 5	134.35 Grams per Liter	Standard Deviation 11.602

Secondary

Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH).

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)	Day -1	29.453 Picograms	Standard Deviation 1.6398
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)	Day 5	30.063 Picograms	Standard Deviation 1.6244
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)	Day -1	29.832 Picograms	Standard Deviation 1.7107
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)	Day 5	29.288 Picograms	Standard Deviation 1.808

Secondary

Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV).

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)	Day -1	85.07 Femtoliters	Standard Deviation 4.009
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)	Day 5	86.50 Femtoliters	Standard Deviation 4.053
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)	Day -1	86.14 Femtoliters	Standard Deviation 4.435
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)	Day 5	85.38 Femtoliters	Standard Deviation 4.273

Secondary

Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count

Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	RBC, Day -1	4.889 Trillion cells per liter	Standard Deviation 0.3357
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	RBC, Day 5	4.703 Trillion cells per liter	Standard Deviation 0.5065
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	Reticulocytes, Day -1	0.064 Trillion cells per liter	Standard Deviation 0.0145
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	Reticulocytes, Day 5	0.073 Trillion cells per liter	Standard Deviation 0.0159
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	Reticulocytes, Day 5	0.065 Trillion cells per liter	Standard Deviation 0.0127
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	RBC, Day -1	5.074 Trillion cells per liter	Standard Deviation 0.5315
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	Reticulocytes, Day -1	0.074 Trillion cells per liter	Standard Deviation 0.0179
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count	RBC, Day 5	4.590 Trillion cells per liter	Standard Deviation 0.2988

Secondary

Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count

Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Basophils, Day -1	0.03 Giga cells per liter	Standard Deviation 0.047
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Basophils, Day 5	0.01 Giga cells per liter	Standard Deviation 0.029
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Eosinophils, Day -1	0.16 Giga cells per liter	Standard Deviation 0.16
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Eosinophils, Day 5	0.15 Giga cells per liter	Standard Deviation 0.094
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Lymphocytes, Day -1	2.02 Giga cells per liter	Standard Deviation 0.699
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Lymphocytes, Day 5	1.90 Giga cells per liter	Standard Deviation 0.367
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Monocytes, Day -1	0.43 Giga cells per liter	Standard Deviation 0.133
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Monocytes, Day 5	0.36 Giga cells per liter	Standard Deviation 0.116
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Neutrophils, Day -1	4.46 Giga cells per liter	Standard Deviation 1.54
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Neutrophils, Day 5	3.20 Giga cells per liter	Standard Deviation 0.954
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Platelet count, Day -1	257.07 Giga cells per liter	Standard Deviation 62.39
Salbutamol HFA-152a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Platelet count, Day 5	235.50 Giga cells per liter	Standard Deviation 37.293
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Platelet count, Day -1	247.64 Giga cells per liter	Standard Deviation 45.865
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Basophils, Day -1	0.02 Giga cells per liter	Standard Deviation 0.037
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Monocytes, Day -1	0.42 Giga cells per liter	Standard Deviation 0.107
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Basophils, Day 5	0.00 Giga cells per liter	Standard Deviation 0
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Neutrophils, Day 5	3.15 Giga cells per liter	Standard Deviation 0.996
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Eosinophils, Day -1	0.15 Giga cells per liter	Standard Deviation 0.142
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Monocytes, Day 5	0.37 Giga cells per liter	Standard Deviation 0.118
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Eosinophils, Day 5	0.18 Giga cells per liter	Standard Deviation 0.124
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Platelet count, Day 5	239.85 Giga cells per liter	Standard Deviation 55.306
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Lymphocytes, Day -1	2.08 Giga cells per liter	Standard Deviation 0.471
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Neutrophils, Day -1	4.24 Giga cells per liter	Standard Deviation 1.117
Salbutamol HFA-134a MDI	Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count	Lymphocytes, Day 5	1.83 Giga cells per liter	Standard Deviation 0.477

Secondary

Absolute Values of Pulse Rate

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 at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 4 h post-dose	62.9 Beats per minute	Standard Deviation 9.11
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Baseline (Day 1, Predose)	58.6 Beats per minute	Standard Deviation 9.43
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 15 min post-dose	70.8 Beats per minute	Standard Deviation 9.54
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 1.5 h post-dose	63.6 Beats per minute	Standard Deviation 8.32
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 2 h post-dose	60.1 Beats per minute	Standard Deviation 7.79
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 4 h post-dose	58.3 Beats per minute	Standard Deviation 8.07
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Baseline (Day 4, Predose)	60.8 Beats per minute	Standard Deviation 9.77
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 30 min post-dose	71.2 Beats per minute	Standard Deviation 9.89
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 1 h post-dose	69.3 Beats per minute	Standard Deviation 10.09
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 1.5 h post-dose	66.1 Beats per minute	Standard Deviation 9.62
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 2 h post-dose	65.1 Beats per minute	Standard Deviation 9.29
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 30 min post-dose	69.4 Beats per minute	Standard Deviation 9.04
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 1, 1 h post-dose	65.9 Beats per minute	Standard Deviation 9.14
Salbutamol HFA-152a MDI	Absolute Values of Pulse Rate	Day 4, 15 min post-dose	74.1 Beats per minute	Standard Deviation 10.81
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 15 min post-dose	69.9 Beats per minute	Standard Deviation 8.41
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 4 h post-dose	58.2 Beats per minute	Standard Deviation 6.84
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 30 min post-dose	73.5 Beats per minute	Standard Deviation 12.86
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Baseline (Day 1, Predose)	61.7 Beats per minute	Standard Deviation 9.75
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 30 min post-dose	66.3 Beats per minute	Standard Deviation 8.26
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 15 min post-dose	71.8 Beats per minute	Standard Deviation 11.43
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 2 h post-dose	60.5 Beats per minute	Standard Deviation 7.88
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 1.5 h post-dose	67.1 Beats per minute	Standard Deviation 11.01
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 1 h post-dose	64.2 Beats per minute	Standard Deviation 8.21
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 2 h post-dose	65.1 Beats per minute	Standard Deviation 11.46
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 1 h post-dose	68.9 Beats per minute	Standard Deviation 12.89
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 1, 4 h post-dose	64.6 Beats per minute	Standard Deviation 10.27
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Day 4, 1.5 h post-dose	62.3 Beats per minute	Standard Deviation 7.66
Salbutamol HFA-134a MDI	Absolute Values of Pulse Rate	Baseline (Day 4, Predose)	55.2 Beats per minute	Standard Deviation 8.23

Secondary

Apparent Terminal Phase Half-life (t1/2) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Salbutamol HFA-152a MDI	Apparent Terminal Phase Half-life (t1/2) of Salbutamol	7.650 hour (h)	Geometric Coefficient of Variation 21.1
Salbutamol HFA-134a MDI	Apparent Terminal Phase Half-life (t1/2) of Salbutamol	7.297 hour (h)	Geometric Coefficient of Variation 17.1

Secondary

Change From Baseline in ECG Parameters: Heart Rate

Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 30 min post-dose	12.0 Beats per minute	Standard Deviation 5.35
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	Baseline (Day 4, Predose)	61.1 Beats per minute	Standard Deviation 8.65
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 1.5 h post-dose	3.9 Beats per minute	Standard Deviation 6.64
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 15 min post-dose	11.4 Beats per minute	Standard Deviation 4.64
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 15 min post-dose	11.7 Beats per minute	Standard Deviation 5.61
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 30 min post-dose	11.0 Beats per minute	Standard Deviation 6.63
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 1 h post-dose	7.5 Beats per minute	Standard Deviation 5.63
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 2 h post-dose	1.6 Beats per minute	Standard Deviation 7.87
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 1.5 h post-dose	4.9 Beats per minute	Standard Deviation 4.82
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 1 h post-dose	7.4 Beats per minute	Standard Deviation 5.37
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 2 h post-dose	3.9 Beats per minute	Standard Deviation 4.36
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 4 h post-dose	-1.6 Beats per minute	Standard Deviation 6.05
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 4 h post-dose	1.6 Beats per minute	Standard Deviation 5.89
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: Heart Rate	Baseline (Day 1, Predose)	59.9 Beats per minute	Standard Deviation 10.01
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 4 h post-dose	-0.7 Beats per minute	Standard Deviation 5.36
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	Baseline (Day 1, Predose)	63.2 Beats per minute	Standard Deviation 8.12
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 30 min post-dose	11.8 Beats per minute	Standard Deviation 5.46
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 15 min post-dose	10.1 Beats per minute	Standard Deviation 6.45
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 30 min post-dose	7.3 Beats per minute	Standard Deviation 8.06
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 1 h post-dose	4.7 Beats per minute	Standard Deviation 7.66
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 1.5 h post-dose	4.7 Beats per minute	Standard Deviation 6.67
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 2 h post-dose	-0.1 Beats per minute	Standard Deviation 6.28
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 1, 4 h post-dose	0.6 Beats per minute	Standard Deviation 7.66
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	Baseline (Day 4, Predose)	57.8 Beats per minute	Standard Deviation 9.53
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 15 min post-dose	14.1 Beats per minute	Standard Deviation 7.03
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 1 h post-dose	8.5 Beats per minute	Standard Deviation 5.58
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 1.5 h post-dose	4.6 Beats per minute	Standard Deviation 4.46
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: Heart Rate	CFB Day 4, 2 h post-dose	3.5 Beats per minute	Standard Deviation 5.8

Secondary

Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval

Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, Baseline (Day 1, Predose)	93.0 Milliseconds	Standard Deviation 9.27
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 15 min post-dose	-11.3 Milliseconds	Standard Deviation 11.74
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 30 min post-dose	-10.7 Milliseconds	Standard Deviation 11.67
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 1 h post-dose	-8.9 Milliseconds	Standard Deviation 13.32
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 1.5 h post-dose	-7.3 Milliseconds	Standard Deviation 9.61
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 2 h post-dose	-4.3 Milliseconds	Standard Deviation 5.62
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 4 h post-dose	-7.2 Milliseconds	Standard Deviation 6.57
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, Baseline (Day 4, Predose)	157.6 Milliseconds	Standard Deviation 18.16
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 15 min post-dose	-10.1 Milliseconds	Standard Deviation 12.11
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 30 min post-dose	-6.2 Milliseconds	Standard Deviation 8.05
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 1 h post-dose	-7.4 Milliseconds	Standard Deviation 11.19
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 1.5 h post-dose	-4.0 Milliseconds	Standard Deviation 9.46
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 2 h post-dose	-8.4 Milliseconds	Standard Deviation 12.49
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 4 h post-dose	-5.4 Milliseconds	Standard Deviation 10.65
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, Baseline (Day 1, Predose)	160.5 Milliseconds	Standard Deviation 25.47
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 15 min post-dose	-1.0 Milliseconds	Standard Deviation 3.72
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 30 min post-dose	-0.9 Milliseconds	Standard Deviation 4.04
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 1 h post-dose	-1.5 Milliseconds	Standard Deviation 3.25
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 1.5 h post-dose	-0.6 Milliseconds	Standard Deviation 3.59
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 2 h post-dose	-0.9 Milliseconds	Standard Deviation 5.9
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 4 h post-dose	-1.2 Milliseconds	Standard Deviation 4.49
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, Baseline (Day 4, Predose)	97.9 Milliseconds	Standard Deviation 8.99
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 15 min post-dose	-1.0 Milliseconds	Standard Deviation 5.43
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 30 min post-dose	-0.2 Milliseconds	Standard Deviation 4.66
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 1 h post-dose	-1.2 Milliseconds	Standard Deviation 5.54
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 1.5 h post-dose	-1.6 Milliseconds	Standard Deviation 5.72
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 2 h post-dose	-0.6 Milliseconds	Standard Deviation 5.76
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 4 h post-dose	-1.6 Milliseconds	Standard Deviation 4.45
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, Baseline (Day 1, Predose)	404.2 Milliseconds	Standard Deviation 27.19
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 15 min post-dose	-29.4 Milliseconds	Standard Deviation 21.45
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 30 min post-dose	-27.0 Milliseconds	Standard Deviation 20.03
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 1 h post-dose	-17.5 Milliseconds	Standard Deviation 11.76
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 1.5 h post-dose	-10.3 Milliseconds	Standard Deviation 13.93
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 2 h post-dose	-4.9 Milliseconds	Standard Deviation 17.13
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 4 h post-dose	3.6 Milliseconds	Standard Deviation 14.9
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, Baseline (Day 4, Predose)	400.8 Milliseconds	Standard Deviation 22.66
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 15 min post-dose	-27.0 Milliseconds	Standard Deviation 11.08
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 30 min post-dose	-21.8 Milliseconds	Standard Deviation 10.66
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 1 h post-dose	-18.0 Milliseconds	Standard Deviation 10.77
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 1.5 h post-dose	-14.1 Milliseconds	Standard Deviation 9.27
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 2 h post-dose	-7.8 Milliseconds	Standard Deviation 9.43
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 4 h post-dose	-3.8 Milliseconds	Standard Deviation 12.7
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, Baseline (Day 1, Predose)	402.1 Milliseconds	Standard Deviation 15.47
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 15 min post-dose	-5.1 Milliseconds	Standard Deviation 21.16
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 30 min post-dose	-2.5 Milliseconds	Standard Deviation 17.3
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 1 h post-dose	-1.4 Milliseconds	Standard Deviation 10.95
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 1.5 h post-dose	-0.2 Milliseconds	Standard Deviation 7.17
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 2 h post-dose	0.3 Milliseconds	Standard Deviation 9.79
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 4 h post-dose	1.1 Milliseconds	Standard Deviation 8.63
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, Baseline (Day 4, Predose)	402.2 Milliseconds	Standard Deviation 14.44
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 15 min post-dose	-4.2 Milliseconds	Standard Deviation 10.18
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 30 min post-dose	-0.2 Milliseconds	Standard Deviation 7.51
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 1 h post-dose	-3.0 Milliseconds	Standard Deviation 10.69
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 1.5 h post-dose	-4.3 Milliseconds	Standard Deviation 8.74
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 2 h post-dose	0.7 Milliseconds	Standard Deviation 9.56
Salbutamol HFA-152a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 4 h post-dose	-0.1 Milliseconds	Standard Deviation 10.27
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 1 h post-dose	1.5 Milliseconds	Standard Deviation 6.15
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, Baseline (Day 1, Predose)	157.1 Milliseconds	Standard Deviation 17.57
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, Baseline (Day 1, Predose)	398.3 Milliseconds	Standard Deviation 19.86
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 15 min post-dose	-6.9 Milliseconds	Standard Deviation 7
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, Baseline (Day 1, Predose)	404.2 Milliseconds	Standard Deviation 14.33
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 30 min post-dose	-3.9 Milliseconds	Standard Deviation 5.14
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 15 min post-dose	-25.8 Milliseconds	Standard Deviation 9.94
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 1 h post-dose	-5.6 Milliseconds	Standard Deviation 7.23
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, Baseline (Day 4, Predose)	397.4 Milliseconds	Standard Deviation 16.3
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 1.5 h post-dose	-2.5 Milliseconds	Standard Deviation 6.72
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 30 min post-dose	-17.5 Milliseconds	Standard Deviation 12.43
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 2 h post-dose	-3.6 Milliseconds	Standard Deviation 8.06
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 15 min post-dose	-7.1 Milliseconds	Standard Deviation 6.37
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 1, 4 h post-dose	-2.6 Milliseconds	Standard Deviation 5.06
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 1 h post-dose	-14.2 Milliseconds	Standard Deviation 13.22
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, Baseline (Day 4, Predose)	159.1 Milliseconds	Standard Deviation 24.95
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 2 h post-dose	0.4 Milliseconds	Standard Deviation 6.21
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 15 min post-dose	-12.5 Milliseconds	Standard Deviation 9.37
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 1.5 h post-dose	-13.0 Milliseconds	Standard Deviation 12.35
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 30 min post-dose	-8.0 Milliseconds	Standard Deviation 8.1
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 30 min post-dose	-4.1 Milliseconds	Standard Deviation 6.8
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 1 h post-dose	-5.3 Milliseconds	Standard Deviation 6.46
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 2 h post-dose	-7.1 Milliseconds	Standard Deviation 12.43
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 1.5 h post-dose	-4.2 Milliseconds	Standard Deviation 7.73
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 15 min post-dose	-1.1 Milliseconds	Standard Deviation 9.09
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 2 h post-dose	-5.7 Milliseconds	Standard Deviation 5.59
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 1, 4 h post-dose	-2.6 Milliseconds	Standard Deviation 15.25
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	PR, CFB to Day 4, 4 h post-dose	-1.4 Milliseconds	Standard Deviation 2.5
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 1 h post-dose	-5.4 Milliseconds	Standard Deviation 7.11
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, Baseline (Day 1, Predose)	98.5 Milliseconds	Standard Deviation 9.18
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, Baseline (Day 4, Predose)	403.5 Milliseconds	Standard Deviation 25.28
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 15 min post-dose	0.3 Milliseconds	Standard Deviation 4.07
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 1.5 h post-dose	-4.7 Milliseconds	Standard Deviation 6.24
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 30 min post-dose	-0.9 Milliseconds	Standard Deviation 5.37
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 15 min post-dose	-29.2 Milliseconds	Standard Deviation 11.67
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 1 h post-dose	-0.9 Milliseconds	Standard Deviation 4.37
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 1.5 h post-dose	-4.4 Milliseconds	Standard Deviation 8.3
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 1.5 h post-dose	-1.5 Milliseconds	Standard Deviation 4.72
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 30 min post-dose	-23.6 Milliseconds	Standard Deviation 7.61
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 2 h post-dose	0.9 Milliseconds	Standard Deviation 5.05
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 30 min post-dose	0.8 Milliseconds	Standard Deviation 9.81
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 1, 4 h post-dose	-0.5 Milliseconds	Standard Deviation 3.88
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 1 h post-dose	-17.3 Milliseconds	Standard Deviation 12.08
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, Baseline (Day 4, Predose)	92.4 Milliseconds	Standard Deviation 7.78
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 2 h post-dose	-7.4 Milliseconds	Standard Deviation 7.76
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 15 min post-dose	-1.0 Milliseconds	Standard Deviation 2.92
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 1.5 h post-dose	-15.0 Milliseconds	Standard Deviation 10.79
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 30 min post-dose	-0.8 Milliseconds	Standard Deviation 2.42
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 4, 4 h post-dose	0.8 Milliseconds	Standard Deviation 4.27
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 1 h post-dose	-0.2 Milliseconds	Standard Deviation 3.03
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 2 h post-dose	-8.0 Milliseconds	Standard Deviation 12.9
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 1.5 h post-dose	0.2 Milliseconds	Standard Deviation 3.27
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QTc interval, CFB to Day 1, 4 h post-dose	-1.1 Milliseconds	Standard Deviation 7.68
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 2 h post-dose	0.8 Milliseconds	Standard Deviation 2.52
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QT interval, CFB to Day 4, 4 h post-dose	1.9 Milliseconds	Standard Deviation 11.72
Salbutamol HFA-134a MDI	Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval	QRS duration, CFB to Day 4, 4 h post-dose	-2.2 Milliseconds	Standard Deviation 4.68

Secondary

Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol

Maximum observed heart rate (HR) after dose is presented.

Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol	74.2 Beats per minute (beats/min)
Salbutamol HFA-134a MDI	Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol	73.4 Beats per minute (beats/min)

Secondary

Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol

Maximum observed QTcF after dose are presented.

Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol	408.7 Milliseconds
Salbutamol HFA-134a MDI	Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol	405.5 Milliseconds

Secondary

Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol

Minimum observed concentration of potassium levels after dose are presented.

Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic population included all participants who received at least one dose of study intervention and have at least one non-missing potassium concentration result. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol	3.94 millimoles per liter (mmol/L)
Salbutamol HFA-134a MDI	Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol	3.96 millimoles per liter (mmol/L)

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

Time frame: Up to 5 days

Population: Safety population included all participants who received at least one dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Salbutamol HFA-152a MDI	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Any TEAEs	9 Participants
Salbutamol HFA-152a MDI	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Any TEAEs	7 Participants
Salbutamol HFA-134a MDI	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Any SAEs	0 Participants

Secondary

Number of Participants With Urinalysis Parameters by Dipstick Method

Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'.

Time frame: On Day -1 (admission) and Day 5 (Discharge)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	Negative	14 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	(+)	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	(+)	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	(+)	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	Negative	14 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	(+)	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	Negative	14 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	(+)	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	Negative	14 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	(+)	1 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	(+)	2 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	Negative	12 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	Negative	14 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	Negative	13 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	(+)	2 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	+	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	++	0 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	Negative	12 Participants
Salbutamol HFA-152a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	(+)	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	+	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	+	1 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	Negative	14 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	++	1 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day -1	Negative	13 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	(+)	1 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	+	1 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	+	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	Negative	12 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	(+)	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	Negative	10 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	+	3 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day -1	Negative	14 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	(+)	1 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	(+)	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day 5	Negative	12 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	+	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	++	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	+	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Glucose, Day 5	Negative	13 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day 5	Negative	12 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	(+)	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Protein, Day 5	(+)	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Ketones, Day -1	+	0 Participants
Salbutamol HFA-134a MDI	Number of Participants With Urinalysis Parameters by Dipstick Method	Urine Hemoglobin, Day -1	(+)	0 Participants

Secondary

Time to Cmax (Tmax) of Salbutamol

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Arm	Measure	Value (MEDIAN)
Salbutamol HFA-152a MDI	Time to Cmax (Tmax) of Salbutamol	2.00 hour (h)
Salbutamol HFA-134a MDI	Time to Cmax (Tmax) of Salbutamol	1.50 hour (h)

Secondary

Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)

Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval.

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)	61.4 Beats per minute (beats/min)
Salbutamol HFA-134a MDI	Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)	60.9 Beats per minute (beats/min)

Secondary

Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)

Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: \[(C2+C1)/2×(t2-t1)\]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval.

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)	384.6 Milliseconds
Salbutamol HFA-134a MDI	Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)	380.8 Milliseconds

Secondary

Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)

Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 \* (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval.

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)

Population: Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
Salbutamol HFA-152a MDI	Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)	4.15 millimoles per liter (mmol/L)
Salbutamol HFA-134a MDI	Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)	4.17 millimoles per liter (mmol/L)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol

AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol

AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol

Maximum Observed Plasma Concentration (Cmax) of Salbutamol

Absolute Values for Chemistry Parameter: Glucose

Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)

Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine

Absolute Values of Clinical Chemistry Parameter: Total Protein

Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Absolute Values of ECG Parameter: Heart Rate

Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval

Absolute Values of Hematology Parameter: Hematocrit

Absolute Values of Hematology Parameter: Hemoglobin

Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count

Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count

Absolute Values of Pulse Rate

Apparent Terminal Phase Half-life (t1/2) of Salbutamol

Change From Baseline in ECG Parameters: Heart Rate

Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval

Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol

Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol

Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Number of Participants With Urinalysis Parameters by Dipstick Method

Time to Cmax (Tmax) of Salbutamol

Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)

Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)

Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)