An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fasting Conditions

NCT01133470 Phase 1 COMPLETED

The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2. Monitor the adverse events and ensure the safety of subjects.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	54
Start date	2007-02
Completion	2007-04

Conditions

• Healthy

Interventions

• Fexofenadine HCl + Pseudoephedrine HCl

Primary outcomes

• Bioequivalence based on Cmax and AUC parameters — 3 months

Countries

India