Fed Clinical Trial
Official title:
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Levocetirizine Dihydrochloride 5 mg Tablets With Xyzal® 5 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fed Condition
This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.
Primary Objective of this pivotal study was to assess the bioequivalence between Test
Product: Levocetirizine Dihydrochloride 5 mg Tablets of M/s Ipca Laboratories Limited, India
and the corresponding Reference Product: Xyzal® (levocetirizine dihydrochloride) 5 mg
Tablets of M/s UCB Inc.,USA, under fed condition in normal, healthy, adult, human subjects
in a randomized crossover study.
Secondary Objective was to monitor the safety and tolerability of a single oral dose of
Levocetirizine Dihydrochloride 5 mg Tablets in normal,healthy, adult, human subjects.
The study was conducted with 28 healthy adult subjects. In each study period, a single 5 mg
dose of either test or reference was administered to the subjects as per the randomization
schedule in each study period with about 240 mL of water at ambient temperature in sitting
position.
The duration of the clinical phase was approximately 11 days including washout period of at
least 7 days between administrations of study drug in each study period.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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