NCT01131728

Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions

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 Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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 fasting conditions.

Detailed description

Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fasting conditions with a washout period of 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Naproxen Sodium & Pseudoephedrine HCl	Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-08-01
• Completion: 2004-09-01
• First posted: 2010-05-27
• Last updated: 2010-06-14

Locations

1 site across 1 country: India