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 Fed Conditions

NCT01506063 Phase 1 COMPLETED

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 fed conditions.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	31
Start date	2008-01
Completion	2008-01

Conditions

• Healthy

Interventions

• Levocetirizine DiHCl

Primary outcomes

• Bioequivalence is based on Cmax and AUC parameters — 1 month

Countries

India