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

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of 10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules in Healthy Adult Male Volunteers Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Amlodipine Besylate / Benazepril Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine Besylate/Benazepril Hydrochloride<br>10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited | Drug: Amlodipine Besylate / Benazepril Hydrochloride<br>* 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules<br>* Other names: Hydrochloride Capsules);|
| Active Comparator: Lotrel<br>Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules) of Novartis | Drug: Amlodipine Besylate / Benazepril Hydrochloride<br>* 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules<br>* Other names: Hydrochloride Capsules);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability based on Cmax and AUC parameters |  | 2 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, 10 mg Amlopdipine besylate /20 mg Benazepril Hydrochloride, Crossover