NCT01131780

Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions

A Randomized, Open Label, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fasting conditions.

Detailed description

This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fasting conditions with a washout period of 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ibuprofen + Pseudoephedrine Hydrochloride	Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-10-01
• Completion: 2004-11-01
• First posted: 2010-05-27
• Last updated: 2010-06-14

Locations

1 site across 1 country: India