NCT01505998

Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions

An Open-label Randomized, Single Dose, Two Way Crossover Oral Bioequivalence Study of Amlodipine Besylate/Benazepril HCl Capsules of Dr. Reddy's With Lotrel® Capsules of Novartis in Human Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.

Detailed description

An open-label randomized, single dose, two way crossover oral bioequivalence study to compare Amlodipine Besylate/Benazepril Hydrochloride 10 mg/40 mg capsules (Dr. Reddy's Laboratories Ltd.,) with Lotrel® capsules Novartis Pharmaceuticals Corporation in healthy human subjects under fed conditions.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Amlodipine Besylate/Benazepril HCl	Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2012-01-09
• Last updated: 2012-01-09

Locations

1 site across 1 country: India