Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Amlodipine Besylate / Benazepril Hydrochloride

• Registration Number: NCT01155908
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under non-fasting (fed) conditions.

Detailed Description

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers under non-fasting (fed) Conditions

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Last Update Submitted: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Healthy adult male volunteers of 18-55 years of age;

• Weighing at least 60 kg within 15% of their ideal weights (Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company 1983)
• Medically healthy subjects with clinically normal laboratory profiles and ECGs;
• Voluntarily consent to participate in the study.

Exclusion Criteria

• History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

• History or presence of:

  • alcoholism or drug abuse within the past year;
  • hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers;
  • hypersensitivity or idiosyncratic reaction to benazepril HCl, benazeprilat or other ACE inhibitors.
  • angioedema or anaphylactic reaction to any substance;

• Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.

• Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.

• Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.

• Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.

• Subjects who have vomited, who have experienced diarrhea or who have undergone vigorous and prolonged exercise (without drinking) within 24 hours prior to dosing.

• Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.

• Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.

• Subjects who have participated in another clinical trial within 28 days prior to the first dose.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrel	Amlodipine Besylate / Benazepril Hydrochloride	Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules) of Novartis
Amlodipine Besylate/Benazepril Hydrochloride	Amlodipine Besylate / Benazepril Hydrochloride	10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited

Primary Outcome Measures

Name	Time	Method
Bioavailability based on Cmax and AUC parameters	2 Months