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

NCT01155908 | Completed Phase 1 DMC

• 1 other identifier: AA15736
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bioavailability based on Cmax and AUC parameters

  2 Months

Study Arms (2)

Amlodipine Besylate/Benazepril Hydrochloride

EXPERIMENTAL

10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited

Drug: Amlodipine Besylate / Benazepril Hydrochloride

Lotrel

ACTIVE COMPARATOR

Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules) of Novartis

Drug: Amlodipine Besylate / Benazepril Hydrochloride

Interventions

Amlodipine Besylate / Benazepril Hydrochloride DRUG

10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules

Also known as: Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril, Hydrochloride Capsules)

Amlodipine Besylate/Benazepril Hydrochloride; Lotrel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

benazepril; Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gaetano Morelli, M.D

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: April 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: July 2, 2010

Record last verified: 2010-07