Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: Male

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 fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Amlodipine; Benazepril

Criteria

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.