Status:
COMPLETED
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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, un...
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...
Eligibility Criteria
Inclusion
- \- 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
- \- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01155908
Start Date
April 1 2005
End Date
May 1 2005
Last Update
July 2 2010
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