NCT01506076

Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg With XYZAL® Tablets 5 mg in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions.

Detailed description

A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy, human subjects under fasting conditions.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Levocetirizine DiHCl	Levocetirizine DiHCl Tablets 5 mg

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2012-01-09
• Last updated: 2012-01-09

Locations

1 site across 1 country: India