NCT01164761

Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions

A Two-way Open Label Crossover Experimental Evaluation of Relative Bioavailabilities of Ramipril 10 mg Capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg Capsules of King Pharmaceuticals in Healthy Adult Human Male Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is * To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting conditions and to assess the bioequivalence. * To monitor the safety of the subjects.

Detailed description

A Two-way open label crossover experimental evaluation of relative bioavailabilities of Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King Pharmaceuticals in healthy adult human male subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ramipril	Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
DRUG	Altace	Altace@ 10 mg capsules of Kings Pharmaceuticals, USA

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-09-01
• Completion: 2005-10-01
• First posted: 2010-07-19
• Last updated: 2010-07-19

Locations

1 site across 1 country: India