NCT01131936

Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions

An Open-Label Randomized Single-Dose Bioequivalence Study of Amlodipine 10 mg Tablets and Norvasc ® 10 mg Tablets Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed conditions.

Detailed description

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine Tablets, 10 mg

Timeline

• Start date: 2002-08-01
• Primary completion: 2002-09-01
• Completion: 2002-11-01
• First posted: 2010-05-27
• Last updated: 2010-06-14

Locations

1 site across 1 country: United States