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

Launched by DR. REDDY'S LABORATORIES LIMITED · Jul 1, 2010

Keywords

ClinConnect Summary

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

Gender

MALE

Eligibility 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.