NCT01888718

Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition

Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of Allegra ® (Containing Fexofenadine Hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - Aventis U.S. LLC, Bridgewater, NJ 08807 in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC, Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor adverse events and ensure the safety of subjects.

Detailed description

An open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of Allegra ® (Containing Fexofenadine Hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - Aventis U.S. LLC, Bridgewater, NJ 08807 in Healthy, Adult, Human Subjects Under Fasting Conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2013-06-28
• Last updated: 2013-06-28

Locations

1 site across 1 country: India