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

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Amlodipine Besylate / Benazepril Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01155908

AA15736

Details and patient eligibility

About

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.

Full 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

Enrollment

48 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.