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

July 1, 2010
July 1, 2010
April 2005
May 2005   (final data collection date for primary outcome measure)
Bioavailability based on Cmax and AUC parameters [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) 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 Non-fasting (Fed) 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 non-fasting (fed) conditions.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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)
  • Experimental: Amlodipine Besylate/Benazepril Hydrochloride
    10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Amlodipine Besylate / Benazepril Hydrochloride
  • Active Comparator: Lotrel
    Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules) of Novartis
    Intervention: Drug: Amlodipine Besylate / Benazepril Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2005
May 2005   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01155908
AA15736
Yes
Senior Manager -Research & Development, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Gaetano Morelli, M.D MDS Pharma Services
Dr. Reddy's Laboratories Limited
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP