A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fed Conditions.

NCT01131767 Phase 1 COMPLETED

The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fed conditions.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	26
Start date	2004-07
Completion	2004-09

Conditions

• Healthy

Interventions

• Naproxen Sodium & Pseudoephedrine HCl

Primary outcomes

• Bioequivalence based on Cmax and AUC parameters — 3 months

Countries

India