NCT01567501

Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Levocetirizine Dihydrochloride tablets 5 mg	5 mg tablet once in a day
DRUG	Levocetirizine Dihydrochloride	5 mg tablet once in a day

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-03-30
• Last updated: 2012-12-03

Locations

1 site across 1 country: India