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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01155895
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 fasting 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 Fasting 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: 54
Study Start Date: March 2004
Study Completion Date: April 2004
Primary Completion Date: March 2004 (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 Fasting 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155895

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: NCT01155895     History of Changes
Other Study ID Numbers: AA15735
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 Amlopdipine besylate /20 mg Benazepril Hydrochloride
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 July 24, 2014