Rhinitis
Conditions
Keywords
Oral disintegrating tablet, Levocetirizine, Immediate release tablet, Bioequivalence, Japanese subjects
Brief summary
This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects. Approximately 48 subjects will participate in this study to receive a single dose treatments of levocetirizine ODT 5 milligram (mg) or levocetirizine IRT 5 mg. In Part 1, subjects will randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose of levocetirizine ODT 5 mg with water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT when taken with water in the fasted state will be assessed. In Part 2, subjects will be randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single dose levocetirizine ODT 5 mg without water or single dose levocetirizine IRT 5 mg with water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be assessed. There will be at least a 5-day wash out period between the intervention periods. The duration of each subject's participation in each part will be approximately 7 weeks from screening to follow-up.
Interventions
DRUGLevocetirizine IRT 5 mg
Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).
DRUGLevocetirizine ODT 5 mg
Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Sponsors
Zensei Pharmaceutical Co., Ltd.
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 20 to 55 years of age inclusive, at the time of signing the informed consent. * Japanese subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Subjects with body weight of \>= 50 kilogram (kg) and body mass index (BMI) within the range of \>=18.5 and \<25.0 kg per meter square (m\^2). * In male subjects contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male subjects are eligible to participate if they agree to the following during the intervention period and until the completion of follow-ups: Refrain from donating sperm; Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1 percentage per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant; Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person. * Subjects must be non-smokers. * Subjects capable of giving signed informed consent.
Exclusion criteria
* Subjects with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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. * Subjects with abnormal blood pressure as determined by the investigator. * Subjects with history of allergic rhinitis. * Subjects with ALT \>1.5x upper limit of normal (ULN). * Subjects with bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percentage). * Subjects with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Subjects with QTc \>450 millisecond (msec). * Subjects with past or intended use of over-the-counter or prescription medication including vitamins, diet supplements (including St. John's wort), herbal medications within 14 days prior to first dosing or 5 half-lives (whichever is longer). * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation within 4 months prior to the first dosing day in this or any other clinical study involving an investigational study intervention or any other type of medical research (except for the subjects with no study intervention administered during any of those enrolment or participation). * The subject with positive serological test for syphilis (Rapid Plasma Reagin \[RPR\] and Treponema pallidum \[TP\] antibody tests), Human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening. * Subject with positive pre-study drug screen. * Subject with regular moderate alcohol consumption within 6 months prior to the study participation defined as: An average weekly intake of \>14 units for males. One unit is equivalent to 360 milliliter (mL) of beer, 150 mL of wine or 45 mL of 80 proof distilled of spirits. * Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study. * History of donation of blood or blood products \>= 400 mL within 3 months or \>=200 mL within 1 month prior to the first dosing day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). |
| Part 2: AUC(0-t) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose | Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). |
| Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. |
| Part 2: Cmax of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose | Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: t1/2 of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: %AUCex of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: CL/F of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: Vz/F of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: Kel (lambda_z) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Mean Residence Time (MRT) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 2: MRT of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 18 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
| Part 2: Number of Participants With AEs and SAEs | Up to 18 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
| Part 1: Change From Baseline in Albumin and Total Protein Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Albumin and Total Protein Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Amylase Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Amylase Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change Form Baseline in Hematocrit | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change Form Baseline in Hematocrit | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Mean Corpuscle Hemoglobin | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Mean Corpuscle Hemoglobin | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Mean Corpuscle Volume | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Mean Corpuscle Volume | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Red Blood Cell Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Red Blood Cell Count | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Reticulocytes | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Reticulocytes | Baseline (Day 1, Pre-dose) and 48 hours post-dose | Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. |
| Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. |
| Part 1: Urine Potential of Hydrogen (pH) | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Part 2: Urine Potential of Hydrogen (pH) | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Part 1: Urine Specific Gravity | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. |
| Part 2: Urine Specific Gravity | Pre-dose (Day 1) and 48 hours post-dose | Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. |
| Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in SBP and DBP | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Heart Rate | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Heart Rate | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Heart Rate (ECG) | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose | Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose | Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: AUC(0-inf) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). |
| Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. |
| Part 2: Tmax of Levocetirizine | Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. |
Countries
Japan
Participant flow
Recruitment details
This was a single center, single dose, open-label, randomized, 2-part, 2-way crossover study. Bioequivalence (BE) between levocetirizine (levo) oral disintegrating tablet (ODT) and levocetirizine immediate release tablet (IRT) was evaluated in 72 healthy Japanese participants.
Pre-assignment details
A total of 133 participants were screened, of them, 72 participants were randomized to receive study treatment. All participants except one participant randomized in Part 2 (Initial study) completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water) All participants received a single oral dose of levocetirizine IRT 5 milligram (mg) tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. | 12 |
| Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg All participants received a single oral dose of levocetirizine ODT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. | 12 |
| Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water) All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. | 24 |
| Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg All participants received a single oral dose of levocetirizine ODT 5 mg tablet without water in fasted state on Day 1 in Period 1. All participants received a single oral dose of levocetirizine IRT 5 mg tablet with water in fasted state on Day 1 in period 2. There was a washout period of at least 5 days between 2 periods. | 24 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part 2:Washout Period (at Least 5 Days) | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: Levo IRT 5 mg Followed by Levo ODT 5 mg (With Water) | Part 1: Levo ODT 5 mg (With Water) Followed by Levo IRT 5 mg | Part 2:Levo IRT 5 mg Followed by Levo ODT 5 mg (Without Water) | Part 2:Levo ODT 5 mg (Without Water) Followed by Levo IRT 5 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.5 Years STANDARD_DEVIATION 6.72 | 31.8 Years STANDARD_DEVIATION 8.93 | 27.0 Years STANDARD_DEVIATION 7 | 26.3 Years STANDARD_DEVIATION 6.48 | 28.0 Years STANDARD_DEVIATION 7.27 |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 12 Participants | 12 Participants | 24 Participants | 24 Participants | 72 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants | 24 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 6 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 48 | 0 / 48 |
Outcome results
Primary
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Population: Pharmacokinetic (PK) Population is defined as all participants who were administered at least one dose of study treatment and blood samples for plasma drug concentration were taken and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine | 1758.5 Hours*nanogram per milliliter (Hr*ng/mL) |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine | 1803.2 Hours*nanogram per milliliter (Hr*ng/mL) |
90% CI: [0.948, 1.003]
Primary
Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine | 219.9 Nanogram per milliliter (ng/mL) |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine | 235.4 Nanogram per milliliter (ng/mL) |
90% CI: [0.875, 0.998]
Primary
Part 2: AUC(0-t) of Levocetirizine
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: AUC(0-t) of Levocetirizine | 1809.9 Hr*ng/mL |
| Part 1: Levocetirizine IRT 5 mg | Part 2: AUC(0-t) of Levocetirizine | 1843.5 Hr*ng/mL |
90% CI: [0.958, 0.998]
Primary
Part 2: Cmax of Levocetirizine
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Cmax of Levocetirizine | 191.5 ng/mL |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Cmax of Levocetirizine | 223.6 ng/mL |
90% CI: [0.815, 0.902]
Secondary
Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine | 2.758 Liters per hour |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine | 2.699 Liters per hour |
Secondary
Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine | 8.784 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine | 8.544 Hours |
Secondary
Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine | 34.95 Liters |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine | 33.27 Liters |
Secondary
Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine | 1812.9 Hr*ng/mL |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine | 1852.5 Hr*ng/mL |
Secondary
Part 1: Change Form Baseline in Hematocrit
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change Form Baseline in Hematocrit | 0.0036 Proportion of red blood cells in blood | Standard Deviation 0.01014 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change Form Baseline in Hematocrit | 0.0043 Proportion of red blood cells in blood | Standard Deviation 0.00952 |
Secondary
Part 1: Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Albumin and Total Protein Levels | Albumin | 1.6 Grams per liter (g/L) | Standard Deviation 1.64 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Albumin and Total Protein Levels | Total protein | 2.7 Grams per liter (g/L) | Standard Deviation 2.16 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Albumin and Total Protein Levels | Albumin | 1.5 Grams per liter (g/L) | Standard Deviation 1.59 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Albumin and Total Protein Levels | Total protein | 2.3 Grams per liter (g/L) | Standard Deviation 2.26 |
Secondary
Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alkaline phosphatase | -0.8 International units per liter (IU/L) | Standard Deviation 8.08 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alanine amino transferase | 0.5 International units per liter (IU/L) | Standard Deviation 3.51 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Aspartate amino transferase | -0.1 International units per liter (IU/L) | Standard Deviation 2.81 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Creatine kinase | -10.0 International units per liter (IU/L) | Standard Deviation 29.62 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Gamma glutamyl transferase | -0.6 International units per liter (IU/L) | Standard Deviation 1.06 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Lactate dehydrogenase | -11.0 International units per liter (IU/L) | Standard Deviation 21.05 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Gamma glutamyl transferase | -0.5 International units per liter (IU/L) | Standard Deviation 1.82 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alkaline phosphatase | -1.6 International units per liter (IU/L) | Standard Deviation 7.81 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Creatine kinase | -13.2 International units per liter (IU/L) | Standard Deviation 11.77 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alanine amino transferase | 1.0 International units per liter (IU/L) | Standard Deviation 3.32 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Lactate dehydrogenase | -8.8 International units per liter (IU/L) | Standard Deviation 10.1 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Aspartate amino transferase | -0.3 International units per liter (IU/L) | Standard Deviation 2.05 |
Secondary
Part 1: Change From Baseline in Amylase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Amylase Levels | 6.3 Units per liter (U/L) | Standard Deviation 7.94 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Amylase Levels | 7.2 Units per liter (U/L) | Standard Deviation 10.62 |
Secondary
Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Eosinophils | -0.53 Percentage | Standard Deviation 0.783 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Monocytes | -0.16 Percentage | Standard Deviation 0.835 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Lymphocytes | -5.94 Percentage | Standard Deviation 6.33 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Total neutrophils levels | 6.64 Percentage | Standard Deviation 6.48 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Basophils | -0.01 Percentage | Standard Deviation 0.15 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Total neutrophils levels | 6.32 Percentage | Standard Deviation 7.95 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Basophils | 0.01 Percentage | Standard Deviation 0.212 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Eosinophils | -0.52 Percentage | Standard Deviation 1.087 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Lymphocytes | -5.96 Percentage | Standard Deviation 7.705 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Monocytes | 0.16 Percentage | Standard Deviation 1.443 |
Secondary
Part 1: Change From Baseline in Body Temperature
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Body Temperature | 1 hour | 0.20 Degree Celsius | Standard Deviation 0.313 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Body Temperature | 24 hour | -0.01 Degree Celsius | Standard Deviation 0.292 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Body Temperature | 48 hour | 0.06 Degree Celsius | Standard Deviation 0.28 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Body Temperature | 1 hour | 0.02 Degree Celsius | Standard Deviation 0.392 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Body Temperature | 24 hour | 0.09 Degree Celsius | Standard Deviation 0.268 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Body Temperature | 48 hour | 0.01 Degree Celsius | Standard Deviation 0.307 |
Secondary
Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Calcium | 0.032227 Millimoles per liter (MMOL/L) | Standard Deviation 0.0490682 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Cholesterol | 0.117448 Millimoles per liter (MMOL/L) | Standard Deviation 0.296715 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Chloride | -0.9 Millimoles per liter (MMOL/L) | Standard Deviation 1.19 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Glucose | -0.067075 Millimoles per liter (MMOL/L) | Standard Deviation 0.2724243 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | High density lipids cholesterol | -0.032325 Millimoles per liter (MMOL/L) | Standard Deviation 0.1006621 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Potassium | 0.13 Millimoles per liter (MMOL/L) | Standard Deviation 0.311 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Low density lipids cholesterol | 0.059263 Millimoles per liter (MMOL/L) | Standard Deviation 0.2661881 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Sodium | -0.6 Millimoles per liter (MMOL/L) | Standard Deviation 1.24 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Phosphorus inorganic | -0.193740 Millimoles per liter (MMOL/L) | Standard Deviation 0.0737556 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Triglycerides | 0.04520 Millimoles per liter (MMOL/L) | Standard Deviation 0.284839 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Urea/BUN | 0.01934 Millimoles per liter (MMOL/L) | Standard Deviation 0.472088 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Triglycerides | -0.00047 Millimoles per liter (MMOL/L) | Standard Deviation 0.304261 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Calcium | 0.018713 Millimoles per liter (MMOL/L) | Standard Deviation 0.0594308 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Potassium | 0.10 Millimoles per liter (MMOL/L) | Standard Deviation 0.33 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Cholesterol | 0.054953 Millimoles per liter (MMOL/L) | Standard Deviation 0.2589722 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Phosphorus inorganic | -0.182977 Millimoles per liter (MMOL/L) | Standard Deviation 0.084988 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Chloride | -1.0 Millimoles per liter (MMOL/L) | Standard Deviation 1.43 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Urea/BUN | 0.08033 Millimoles per liter (MMOL/L) | Standard Deviation 0.49894 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Glucose | -0.050884 Millimoles per liter (MMOL/L) | Standard Deviation 0.2037377 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Sodium | -0.7 Millimoles per liter (MMOL/L) | Standard Deviation 1.49 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | Low density lipids cholesterol | 0.038790 Millimoles per liter (MMOL/L) | Standard Deviation 0.2158221 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels | High density lipids cholesterol | -0.063573 Millimoles per liter (MMOL/L) | Standard Deviation 0.0806953 |
Secondary
Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin | 0.214 Micromoles per liter (UMOL/L) | Standard Deviation 0.9178 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin | 0.143 Micromoles per liter (UMOL/L) | Standard Deviation 3.3034 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Creatinine | -1.9522 Micromoles per liter (UMOL/L) | Standard Deviation 4.20313 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Uric acid | 21.0658 Micromoles per liter (UMOL/L) | Standard Deviation 22.25394 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Uric acid | 23.2963 Micromoles per liter (UMOL/L) | Standard Deviation 27.33699 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin | 0.356 Micromoles per liter (UMOL/L) | Standard Deviation 1.0059 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Creatinine | -1.9890 Micromoles per liter (UMOL/L) | Standard Deviation 4.09064 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin | -1.710 Micromoles per liter (UMOL/L) | Standard Deviation 4.034 |
Secondary
Part 1: Change From Baseline in Heart Rate
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Heart Rate | 1 hour | -2.3 Beats per minute | Standard Deviation 4.77 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Heart Rate | 24 hour | -0.8 Beats per minute | Standard Deviation 5.24 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Heart Rate | 48 hour | 0.8 Beats per minute | Standard Deviation 6.13 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Heart Rate | 1 hour | -0.9 Beats per minute | Standard Deviation 4.62 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Heart Rate | 24 hour | -0.1 Beats per minute | Standard Deviation 5.5 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Heart Rate | 48 hour | 2.5 Beats per minute | Standard Deviation 5.9 |
Secondary
Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | 1 hour | 1.6 Beats per minute | Standard Deviation 4.8 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | 48 hour | 2.1 Beats per minute | Standard Deviation 4.37 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | 1 hour | 1.0 Beats per minute | Standard Deviation 4.47 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) | 48 hour | 2.5 Beats per minute | Standard Deviation 4.74 |
Secondary
Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Hemoglobin | 2.2 Grams per liter (G/L) | Standard Deviation 3.81 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Mean corpuscle hemoglobin concentration | 2.3 Grams per liter (G/L) | Standard Deviation 4.16 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Hemoglobin | 2.3 Grams per liter (G/L) | Standard Deviation 3.44 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Mean corpuscle hemoglobin concentration | 1.8 Grams per liter (G/L) | Standard Deviation 4.64 |
Secondary
Part 1: Change From Baseline in Mean Corpuscle Hemoglobin
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Mean Corpuscle Hemoglobin | -0.04 Picograms | Standard Deviation 0.313 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Mean Corpuscle Hemoglobin | -0.03 Picograms | Standard Deviation 0.288 |
Secondary
Part 1: Change From Baseline in Mean Corpuscle Volume
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Mean Corpuscle Volume | -0.6 Femtoliters | Standard Deviation 0.83 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Mean Corpuscle Volume | -0.5 Femtoliters | Standard Deviation 0.83 |
Secondary
Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | Platelet count | -6.4 Giga per liter (GI/L) | Standard Deviation 12.62 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | White blood cell count | -0.94 Giga per liter (GI/L) | Standard Deviation 0.95 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | Platelet count | -11.4 Giga per liter (GI/L) | Standard Deviation 11.64 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count | White blood cell count | -1.26 Giga per liter (GI/L) | Standard Deviation 0.596 |
Secondary
Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 1 hour | -7.3 Millisecond | Standard Deviation 12.16 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 48 hour | -5.5 Millisecond | Standard Deviation 10.72 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 1 hour | -0.5 Millisecond | Standard Deviation 3.4 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 48 hour | 1.7 Millisecond | Standard Deviation 3.67 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 1 hour | -9.3 Millisecond | Standard Deviation 17.3 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 48 hour | -14.3 Millisecond | Standard Deviation 16 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 1 hour | -6.1 Millisecond | Standard Deviation 14.06 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 48 hour | -9.3 Millisecond | Standard Deviation 14.67 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 48 hour | -4.8 Millisecond | Standard Deviation 17.96 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 1 hour | -6.3 Millisecond | Standard Deviation 10 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 1 hour | -6.4 Millisecond | Standard Deviation 15.38 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 48 hour | -1.9 Millisecond | Standard Deviation 13.03 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 1 hour | -4.3 Millisecond | Standard Deviation 11.52 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 1 hour | -0.8 Millisecond | Standard Deviation 5.24 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 48 hour | -10.7 Millisecond | Standard Deviation 18.17 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 48 hour | -0.6 Millisecond | Standard Deviation 6.37 |
Secondary
Part 1: Change From Baseline in Red Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Red Blood Cell Count | 0.078 Trillion cells per liter | Standard Deviation 0.1189 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Red Blood Cell Count | 0.080 Trillion cells per liter | Standard Deviation 0.1235 |
Secondary
Part 1: Change From Baseline in Reticulocytes
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Reticulocytes | -0.0001 Percentage of reticulocytes | Standard Deviation 0.00167 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Reticulocytes | 0.0004 Percentage of reticulocytes | Standard Deviation 0.00186 |
Secondary
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 1 hour | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 9.68 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 hour | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 7.23 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 48 hour | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.64 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 1 hour | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 5.67 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 hour | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 4.47 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 48 hour | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 6.98 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 hour | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 6.19 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 1 hour | 0.4 Millimeters of mercury (mmHg) | Standard Deviation 8.54 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 1 hour | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 6.84 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 hour | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 7.2 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 48 hour | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 48 hour | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 7.51 |
Secondary
Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine
Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine | 0.07891 Per hour |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine | 0.08113 Per hour |
Secondary
Part 1: Mean Residence Time (MRT) of Levocetirizine
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Mean Residence Time (MRT) of Levocetirizine | 11.545 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Mean Residence Time (MRT) of Levocetirizine | 11.417 Hours |
Secondary
Part 1: Number of Participants With Adverse Events (AEs) 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 intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time frame: Up to 18 days
Population: Safety Population consists of all participants who were administered at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, trace | 1 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, positive (1+) | 0 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, negative | 23 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, negative | 23 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Protein, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, trace | 1 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Protein, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, Pre-dose, trace | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, 48 hours, trace | 24 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, 48 hours, trace | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, trace | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, negative | 23 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, positive (1+) | 1 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Protein, Pre-dose, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Protein, 48 hours, negative | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, Pre-dose, trace | 24 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, trace | 0 Participants |
Secondary
Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine | 2.772 Percentage AUCex |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine | 2.500 Percentage AUCex |
Secondary
Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine | 0.5000 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine | 0.7500 Hours |
Secondary
Part 1: Urine Potential of Hydrogen (pH)
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Urine Potential of Hydrogen (pH) | Pre-dose | 6.04 pH | Standard Deviation 0.359 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Urine Potential of Hydrogen (pH) | 48 hours | 6.10 pH | Standard Deviation 0.329 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Urine Potential of Hydrogen (pH) | Pre-dose | 6.06 pH | Standard Deviation 0.34 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Urine Potential of Hydrogen (pH) | 48 hours | 6.02 pH | Standard Deviation 0.275 |
Secondary
Part 1: Urine Specific Gravity
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 1: Urine Specific Gravity | Pre-dose | 1.0158 Ratio | Standard Deviation 0.00724 |
| Part 1: Levocetirizine ODT 5 mg | Part 1: Urine Specific Gravity | 48 hours | 1.0178 Ratio | Standard Deviation 0.00751 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Urine Specific Gravity | Pre-dose | 1.0144 Ratio | Standard Deviation 0.00658 |
| Part 1: Levocetirizine IRT 5 mg | Part 1: Urine Specific Gravity | 48 hours | 1.0163 Ratio | Standard Deviation 0.00798 |
Secondary
Part 2: AUC(0-inf) of Levocetirizine
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: AUC(0-inf) of Levocetirizine | 1869.5 Hr*ng/mL |
| Part 1: Levocetirizine IRT 5 mg | Part 2: AUC(0-inf) of Levocetirizine | 1900.2 Hr*ng/mL |
Secondary
Part 2: %AUCex of Levocetirizine
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: %AUCex of Levocetirizine | 2.973 Percentage AUCex |
| Part 1: Levocetirizine IRT 5 mg | Part 2: %AUCex of Levocetirizine | 2.779 Percentage AUCex |
Secondary
Part 2: Change Form Baseline in Hematocrit
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change Form Baseline in Hematocrit | 0.0023 Proportion of red blood cells in blood | Standard Deviation 0.01505 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change Form Baseline in Hematocrit | 0.0019 Proportion of red blood cells in blood | Standard Deviation 0.01595 |
Secondary
Part 2: Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Albumin and Total Protein Levels | Albumin | 1.2 g/L | Standard Deviation 2.08 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Albumin and Total Protein Levels | Total protein | 1.8 g/L | Standard Deviation 3.02 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Albumin and Total Protein Levels | Albumin | 1.4 g/L | Standard Deviation 2.17 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Albumin and Total Protein Levels | Total protein | 1.9 g/L | Standard Deviation 3.34 |
Secondary
Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alkaline phosphatase | -1.1 IU/L | Standard Deviation 13.46 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Aspartate amino transferase | 0.1 IU/L | Standard Deviation 1.65 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Lactate dehydrogenase | -3.5 IU/L | Standard Deviation 10.52 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Creatine kinase | -12.4 IU/L | Standard Deviation 16.24 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alanine amino transferase | -0.5 IU/L | Standard Deviation 2.05 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Gamma glutamyl transferase | -0.1 IU/L | Standard Deviation 1.28 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alanine amino transferase | -0.7 IU/L | Standard Deviation 2.63 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Lactate dehydrogenase | -3.7 IU/L | Standard Deviation 11.55 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Alkaline phosphatase | -2.3 IU/L | Standard Deviation 14.17 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Gamma glutamyl transferase | -0.1 IU/L | Standard Deviation 1.52 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Aspartate amino transferase | -0.1 IU/L | Standard Deviation 2.58 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels | Creatine kinase | -16.3 IU/L | Standard Deviation 20.93 |
Secondary
Part 2: Change From Baseline in Amylase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Amylase Levels | 7.4 U/L | Standard Deviation 6.69 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Amylase Levels | 7.1 U/L | Standard Deviation 10.13 |
Secondary
Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Eosinophils | -0.92 Percentage | Standard Deviation 1.183 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Monocytes | -0.49 Percentage | Standard Deviation 1.046 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Lymphocytes | -8.45 Percentage | Standard Deviation 6.915 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Total neutrophils levels | 9.78 Percentage | Standard Deviation 7.094 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Basophils | 0.08 Percentage | Standard Deviation 0.195 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Total neutrophils levels | 9.25 Percentage | Standard Deviation 5.847 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Basophils | 0.04 Percentage | Standard Deviation 0.176 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Eosinophils | -0.74 Percentage | Standard Deviation 1.012 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Lymphocytes | -8.07 Percentage | Standard Deviation 5.558 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count | Monocytes | -0.48 Percentage | Standard Deviation 1.087 |
Secondary
Part 2: Change From Baseline in Body Temperature
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Body Temperature | 1 hour | 0.19 Degree Celsius | Standard Deviation 0.362 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Body Temperature | 24 hour | 0.13 Degree Celsius | Standard Deviation 0.272 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Body Temperature | 48 hour | 0.03 Degree Celsius | Standard Deviation 0.351 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Body Temperature | 1 hour | 0.09 Degree Celsius | Standard Deviation 0.359 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Body Temperature | 24 hour | 0.08 Degree Celsius | Standard Deviation 0.324 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Body Temperature | 48 hour | 0.03 Degree Celsius | Standard Deviation 0.345 |
Secondary
Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Low density lipids cholesterol | 0.123374 MMOL/L | Standard Deviation 0.1986158 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Calcium | 0.015594 MMOL/L | Standard Deviation 0.0623219 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Phosphorus inorganic | -0.203831 MMOL/L | Standard Deviation 0.125175 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Potassium | -0.03 MMOL/L | Standard Deviation 0.233 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Cholesterol | 0.083506 MMOL/L | Standard Deviation 0.2666316 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Triglycerides | -0.02707 MMOL/L | Standard Deviation 0.290907 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Chloride | -0.6 MMOL/L | Standard Deviation 1.17 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Sodium | -1.1 MMOL/L | Standard Deviation 1.28 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Glucose | -0.049728 MMOL/L | Standard Deviation 0.2525006 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Urea/BUN | -0.12272 MMOL/L | Standard Deviation 0.622969 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | High density lipids cholesterol | -0.049565 MMOL/L | Standard Deviation 0.1151357 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Urea/BUN | -0.45802 MMOL/L | Standard Deviation 0.817628 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Low density lipids cholesterol | 0.084733 MMOL/L | Standard Deviation 0.1846539 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Sodium | -0.6 MMOL/L | Standard Deviation 1.05 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Phosphorus inorganic | -0.239770 MMOL/L | Standard Deviation 0.1230018 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Triglycerides | 0.03606 MMOL/L | Standard Deviation 0.206604 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | High density lipids cholesterol | -0.047869 MMOL/L | Standard Deviation 0.0975044 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Potassium | 0.08 MMOL/L | Standard Deviation 0.368 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Calcium | 0.015926 MMOL/L | Standard Deviation 0.070459 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Cholesterol | 0.064925 MMOL/L | Standard Deviation 0.2594347 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Chloride | -0.5 MMOL/L | Standard Deviation 1.35 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels | Glucose | 0.059053 MMOL/L | Standard Deviation 0.2990211 |
Secondary
Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin | -0.071 UMOL/L | Standard Deviation 0.7018 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin | -0.748 UMOL/L | Standard Deviation 3.0325 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Creatinine | -3.5913 UMOL/L | Standard Deviation 4.21949 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Uric acid | 14.0026 UMOL/L | Standard Deviation 20.14225 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Uric acid | 13.6677 UMOL/L | Standard Deviation 28.30678 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin | 0.036 UMOL/L | Standard Deviation 0.7555 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Creatinine | -3.8746 UMOL/L | Standard Deviation 5.00254 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin | -0.619 UMOL/L | Standard Deviation 3.1374 |
Secondary
Part 2: Change From Baseline in Heart Rate
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Heart Rate | 1 hour | -1.5 Beats per minute | Standard Deviation 8.34 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Heart Rate | 24 hour | -1.9 Beats per minute | Standard Deviation 9.16 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Heart Rate | 48 hour | 1.5 Beats per minute | Standard Deviation 10.85 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Heart Rate | 1 hour | -0.6 Beats per minute | Standard Deviation 5.24 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Heart Rate | 24 hour | 0.6 Beats per minute | Standard Deviation 6.91 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Heart Rate | 48 hour | 3.0 Beats per minute | Standard Deviation 9.08 |
Secondary
Part 2: Change From Baseline in Heart Rate (ECG)
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Heart Rate (ECG) | 1 hour | -1.0 Beats per minute | Standard Deviation 5.72 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Heart Rate (ECG) | 48 hour | 1.7 Beats per minute | Standard Deviation 8.22 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Heart Rate (ECG) | 1 hour | -1.7 Beats per minute | Standard Deviation 5.83 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Heart Rate (ECG) | 48 hour | 1.9 Beats per minute | Standard Deviation 8.05 |
Secondary
Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Hemoglobin | 0.9 G/L | Standard Deviation 4.87 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Mean corpuscle hemoglobin concentration | 0.2 G/L | Standard Deviation 4.12 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Hemoglobin | 0.9 G/L | Standard Deviation 5.69 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration | Mean corpuscle hemoglobin concentration | 0.5 G/L | Standard Deviation 3.87 |
Secondary
Part 2: Change From Baseline in Mean Corpuscle Hemoglobin
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Mean Corpuscle Hemoglobin | -0.07 Picograms | Standard Deviation 0.305 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Mean Corpuscle Hemoglobin | -0.07 Picograms | Standard Deviation 0.265 |
Secondary
Part 2: Change From Baseline in Mean Corpuscle Volume
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Mean Corpuscle Volume | -0.2 Femtoliters | Standard Deviation 0.81 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Mean Corpuscle Volume | -0.3 Femtoliters | Standard Deviation 0.63 |
Secondary
Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | Platelet count | -2.5 GI/L | Standard Deviation 12.71 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | White blood cell count | -1.14 GI/L | Standard Deviation 1.246 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | Platelet count | -2.9 GI/L | Standard Deviation 13.98 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count | White blood cell count | -1.06 GI/L | Standard Deviation 1.133 |
Secondary
Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 48 hour | 0.3 Millisecond | Standard Deviation 6.5 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 1 hour | -3.2 Millisecond | Standard Deviation 11.67 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 48 hour | 1.2 Millisecond | Standard Deviation 11.48 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 1 hour | -1.4 Millisecond | Standard Deviation 5.53 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 1 hour | 3.8 Millisecond | Standard Deviation 14.45 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 48 hour | -12.1 Millisecond | Standard Deviation 17.36 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 1 hour | 1.4 Millisecond | Standard Deviation 15.35 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 48 hour | -8.5 Millisecond | Standard Deviation 15.75 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 48 hour | -7.6 Millisecond | Standard Deviation 14.87 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 1 hour | 3.1 Millisecond | Standard Deviation 18.94 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 1 hour | -2.8 Millisecond | Standard Deviation 8.66 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QTcF interval, 1 hour | -0.9 Millisecond | Standard Deviation 17.35 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | PR interval, 48 hour | 0.6 Millisecond | Standard Deviation 9.76 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QT interval, 48 hour | -11.4 Millisecond | Standard Deviation 20.49 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 1 hour | -1.9 Millisecond | Standard Deviation 7.99 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval | QRS duration, 48 hour | -0.4 Millisecond | Standard Deviation 7.17 |
Secondary
Part 2: Change From Baseline in Red Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Red Blood Cell Count | 0.040 Trillion cells per liter | Standard Deviation 0.173 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Red Blood Cell Count | 0.041 Trillion cells per liter | Standard Deviation 0.1883 |
Secondary
Part 2: Change From Baseline in Reticulocytes
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in Reticulocytes | -0.0001 Percentage of reticulocytes | Standard Deviation 0.00173 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in Reticulocytes | -0.0004 Percentage of reticulocytes | Standard Deviation 0.00169 |
Secondary
Part 2: Change From Baseline in SBP and DBP
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 24 hour | -2.3 mmHg | Standard Deviation 6.11 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 1 hour | -2.6 mmHg | Standard Deviation 7.07 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 24 hour | -1.9 mmHg | Standard Deviation 7.69 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 48 hour | 0.7 mmHg | Standard Deviation 9.95 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 48 hour | -0.6 mmHg | Standard Deviation 7.15 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 1 hour | 0.2 mmHg | Standard Deviation 9.22 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 48 hour | -0.2 mmHg | Standard Deviation 6.22 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 1 hour | -0.9 mmHg | Standard Deviation 8.27 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 24 hour | -1.2 mmHg | Standard Deviation 9.16 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | SBP, 48 hour | 0.3 mmHg | Standard Deviation 9.15 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 1 hour | -2.6 mmHg | Standard Deviation 6.35 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Change From Baseline in SBP and DBP | DBP, 24 hour | -1.2 mmHg | Standard Deviation 6.23 |
Secondary
Part 2: CL/F of Levocetirizine
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: CL/F of Levocetirizine | 2.675 Liters per hour |
| Part 1: Levocetirizine IRT 5 mg | Part 2: CL/F of Levocetirizine | 2.631 Liters per hour |
Secondary
Part 2: Kel (lambda_z) of Levocetirizine
Blood samples were collected at indicated time points for analysis of kel. kel (lambda\_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Kel (lambda_z) of Levocetirizine | 0.07681 Per hour |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Kel (lambda_z) of Levocetirizine | 0.07760 Per hour |
Secondary
Part 2: MRT of Levocetirizine
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: MRT of Levocetirizine | 12.573 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 2: MRT of Levocetirizine | 12.272 Hours |
Secondary
Part 2: Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time frame: Up to 18 days
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With AEs and SAEs | AEs | 6 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With AEs and SAEs | SAEs | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With AEs and SAEs | AEs | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With AEs and SAEs | SAEs | 0 Participants |
Secondary
Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, Pre-dose, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, positive (1+) | 0 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, trace | 1 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, 48 hours, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Protein, Pre-dose, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, Pre-dose, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Protein, 48 hours, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, 48 hours, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, 48 hours, negative | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, 48 hours, trace | 48 Participants |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, Pre-dose, trace | 48 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, 48 hours, trace | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, Pre-dose, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Bilirubin, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, Pre-dose, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Occult blood, 48 hours, trace | 0 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, Pre-dose, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Glucose, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, negative | 46 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, Pre-dose, positive (1+) | 1 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Ketones, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Protein, Pre-dose, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Protein, 48 hours, negative | 47 Participants |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Number of Participants With Urinalysis Results by Dipstick Method | Urobilinogen, Pre-dose, trace | 47 Participants |
Secondary
Part 2: t1/2 of Levocetirizine
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: t1/2 of Levocetirizine | 9.024 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 2: t1/2 of Levocetirizine | 8.933 Hours |
Secondary
Part 2: Tmax of Levocetirizine
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Tmax of Levocetirizine | 1.0000 Hours |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Tmax of Levocetirizine | 1.0000 Hours |
Secondary
Part 2: Urine Potential of Hydrogen (pH)
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Urine Potential of Hydrogen (pH) | Pre-dose | 6.20 pH | Standard Deviation 0.353 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Urine Potential of Hydrogen (pH) | 48 hours | 6.09 pH | Standard Deviation 0.395 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Urine Potential of Hydrogen (pH) | 48 hours | 6.00 pH | Standard Deviation 0.376 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Urine Potential of Hydrogen (pH) | Pre-dose | 6.11 pH | Standard Deviation 0.345 |
Secondary
Part 2: Urine Specific Gravity
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.
Time frame: Pre-dose (Day 1) and 48 hours post-dose
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Urine Specific Gravity | Pre-dose | 1.0156 Ratio | Standard Deviation 0.00646 |
| Part 1: Levocetirizine ODT 5 mg | Part 2: Urine Specific Gravity | 48 hours | 1.0160 Ratio | Standard Deviation 0.00669 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Urine Specific Gravity | 48 hours | 1.0159 Ratio | Standard Deviation 0.00749 |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Urine Specific Gravity | Pre-dose | 1.0179 Ratio | Standard Deviation 0.00666 |
Secondary
Part 2: Vz/F of Levocetirizine
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).
Time frame: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: Levocetirizine ODT 5 mg | Part 2: Vz/F of Levocetirizine | 34.82 Liters |
| Part 1: Levocetirizine IRT 5 mg | Part 2: Vz/F of Levocetirizine | 33.91 Liters |