Healthy
Conditions
Keywords
Bioavailability, 10 mg Amlopdipine besylate /20 mg Benazepril Hydrochloride, Crossover
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 fasting 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 Fasting Conditions
Interventions
10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability based on Cmax and AUC parameters | 2 Months |
Outcome results
None listed