Pharmacokinetic Study of Levocetirizine Oral Solution
This study will be a single center, open-label, randomized, single dose, in the fasted condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese healthy male subjects.
Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose.
The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in Japanese healthy male subjects.
Rhinitis, Allergic, Perennial and Seasonal
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Pharmacokinetic Study of Levocetirizine Oral Solution -An Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, the Safety and Tolerability of Levocetirizine Oral Solution (5 mg) and Cetirizine Dry Syrup (10 mg), Following a Single Dose in Japanese Healthy Male Subjects-|
- AUC(0-48) of levocetirizine [ Time Frame: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose ]AUC(0-48): Area under plasma concentration time curve from pre-dose to 48h.
- Cmax of levocetirizine [ Time Frame: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose ]Cmax: Maximum observed concentration.
- Adverse events [ Time Frame: up to 48h post dose ]Number of participants with adverse events as a measure of safety and tolerability.
- Safety and tolerability [ Time Frame: up to 48h post dose ]Safety and tolerability of levocetirizine and cetirizine in terms of clinical laboratory tests, vital sign, body weight and ECG.
- Vital sign [ Time Frame: up to 48h post dose ]Systolic and diastolic blood pressure, body temperature and pulse rate.
- Body weight [ Time Frame: up to 48h post dose ]
- ECG [ Time Frame: up to 48h post dose ]Heart rate, PR, QRS, QT, and QTc intervals.
- Laboratory tests [ Time Frame: up to 48h post dose ]Clinical Chemistry (Total Protein, Albumin, Total and Direct Bilirubin, BUN, Creatinine, Uric Acid, TG, Total Cholesterol, LDL and HDL-cholesterol, AST, ALT, Alkaline Phosphatase, LDH, GGT, CPK, Amylase, Glucose(fasting), Sodium, Potassium, Chloride, Calcium, Phosphorus), Hematology (Platelet Count, RBC Count, WBC Count (absolute), Reticulocyte Count, Hemoglobin, Hematocrit, RBC Indices (MCV, MCH, MCHC) and Automated WBC Differential (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils)) and Urinalysis (Specific Gravity, pH, Glucose, Protein, Blood, Ketones and Microscopic Examination)
- AUC(0-inf), MRT, tmax, and t1/2 of levocetirizine [ Time Frame: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose ]AUC(0-inf): Area under the concentration-time curve from time pre-dose extrapolated to infinite time, MRT: Mean residence time, tmax: Time of occurrence of Cmax, and t1/2: Terminal phase half-life.
|Study Start Date:||May 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Levocetirizine oral solution 5 mg
Levocetirizine oral solution 5 mg
Active Comparator: Cetirizine dry syrup 10 mg
Cetirizine dry syrup 10 mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622283
|GSK Investigational Site|
|Kagoshima, Japan, 890-0081|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|