NCT01066754

Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets and Allegra® 180 mg Tablets Administered as 1 x 180 mg Tablet in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets, Aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under Fasting Conditions

Detailed description

The objective of this study is to compare the rate and extent of absorption of fexofenadine hydrochloride 180 mg tablets (test) versus Allegra® (reference) administered as 1 x 180 mg tablet under fasting conditions. Single oral dose (1 x 180 mg) in each period with a washout of at least 7 days between doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fexofenadine	Fexofenadine Hydrochloride 180 mg Tablets

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-05-01
• Completion: 2002-05-01
• First posted: 2010-02-10
• Last updated: 2010-02-10

Locations

1 site across 1 country: Canada