Rhinitis, Allergic, Perennial and Seasonal Clinical Trial
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-
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.
n/a
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