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Open Label,Balanced,Randomized,Two-treatment,Two-sequence,Two Period,Single-dose,Crossover Oral Bioequivalence Study of Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets of Dr.Reddy's and Advil®PM of Wyeth in Normal,Healthy,Adult,Human Subjects Under Fasting Conditions.

NCT01053208 Phase 1 COMPLETED

To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting conditions.

Details

Lead sponsorDr. Reddy's Laboratories Limited
PhasePhase 1
StatusCOMPLETED
Enrolment40
Start date2008-04
Completion2008-04

Conditions

Interventions

Primary outcomes

Countries

India