An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover, Bioavailability Study Comparing Ramipril 10 mg Capsules of OHM Laboratories Inc (a Subsidiary of Ranbaxy Pharmaceuticals Inc) With ALTACE® 10 mg Capsules (Containing Ramipril 10 mg) of King Pharmaceuticals Inc, in Healthy, Adult, Male Human Subjects Under Fasting Condition.

Ranbaxy Laboratories Limited1 site in 1 country68 target enrollmentJanuary 2007

ConditionsHealthy

InterventionsRamipril 10mg capsules

DrugsRamipril 10mg capsules

Overview

Phase: Not Applicable
Intervention: Ramipril 10mg capsules
Conditions: Healthy
Sponsor: Ranbaxy Laboratories Limited
Enrollment: 68
Locations: 1
Primary Endpoint: Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fasting conditions
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg of OHM Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under fasting condition.

Detailed Description

Following an overnight fast of at least 10 hour, a single oral dose of ramipril 10 mg capsule was administered during each period of the study, along with 240 mL of drinking water at ambient temperature, under low light condition and supervision of trained study personnel. A total of sixty-eight (68) subjects were enrolled into the study, to be administered a single oral dose of the test or reference formulation of ramipril 10 mg capsule according to a randomization schedule. Two subjects (subject numbers 01 and 06) were withdrawn from the study in period I and subject number 02 did not report for period II. Sixty-five (65) subjects completed both the periods of the study.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

March 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Ranbaxy Laboratories Limited

Eligibility Criteria

Inclusion Criteria

•Were in the age range of 18-45 years.
•Were neither overweight nor underweight for the corresponding height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
•Had voluntarily given written informed consent to participate in this study.
•Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria

•Hypersensitivity or allergy to ramipril or related group of drugs.
•Subject who had sitting systolic blood pressure of less than 90 mmHg or \>140 mmHg and diastolic blood pressure of less than 60 mmHg or \> 90 mm Hg at screening
•History of hypertension, hypotension, angina, myocardial infarction or angioedema.
•Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
•History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma or angioedema due to any cause.
•History of any psychiatric illness which might impair the ability to provide written informed consent.
•Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
•Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
•Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
•Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.