Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions

NCT01373138 Phase 1 COMPLETED

This is an open label randomised, 2-way crossover, comparative bioequivalence study.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	34
Start date	2006-04
Completion	2006-05

Conditions

• Healthy

Interventions

• Desloratadine and pseudoephedrine

Primary outcomes

• Bioequivalence based on Cmax and AUC parameters — 3 months

Countries

Canada