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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Amlodipine Besylate / Benazepril Hydrochloride

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Gaetano Morelli, M.D, MDS Pharma Services

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2010
• Last Update Submitted That Met QC Criteria: July 1, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Crossover; Bioavailability; 10 mg Amlopdipine besylate /20 mg Benazepril Hydrochloride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Amlodipine; Benazepril
• Other Study ID Numbers: AA15735