Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
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
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
Fexofenadine
Location
Anapharm Inc.,
Sainte-Foy Quebec
Canada
G1V 2K8
Status
Completed
Source
Dr. Reddy's Laboratories Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01066754
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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