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

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Amlodipine Besylate / Benazepril Hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Gaetano Morelli, M.D, Principal Investigator, Affiliation: MDS Pharma Services

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioavailability based on Cmax and AUC parameters

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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.

Locations and Contacts

Additional Information

Starting date: April 2005
Last updated: July 1, 2010

Page last updated: August 23, 2015

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