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

• ClinicalTrials.gov Identifier: NCT01155908
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Sponsor: Dr. Reddy's Laboratories Limited
• Information provided by: Dr. Reddy's Laboratories Limited

Study Description

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 non-fasting (fed) conditions.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Amlodipine Besylate / Benazepril Hydrochloride	Phase 1

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 non-fasting (fed) Conditions

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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 Non-fasting (Fed) Conditions
• Study Start Date: April 2005
• Actual Primary Completion Date: May 2005
• Actual Study Completion Date: May 2005

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Bioavailability based on Cmax and AUC parameters [ Time Frame: 2 Months ]

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Gaetano Morelli, M.D; MDS Pharma Services

More Information

• Responsible Party: Senior Manager -Research & Development, Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT01155908
• Other Study ID Numbers: AA15736
• First Posted: July 2, 2010
• Last Update Posted: July 2, 2010
• Last Verified: July 2010

Keywords provided by Dr. Reddy's Laboratories Limited:

Bioavailability; 10 mg Amlodipine besylate/20 mg benazepril hydrochloride capsules; Crossover

Additional relevant MeSH terms:

Amlodipine; Benazepril; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Enzyme Inhibitors