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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01155908
First received: July 1, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
Drug: Amlodipine Besylate / Benazepril Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 2 Months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155908

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Gaetano Morelli, M.D MDS Pharma Services
  More Information

No publications provided

Responsible Party: Senior Manager -Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01155908     History of Changes
Other Study ID Numbers: AA15736
Study First Received: July 1, 2010
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014