NCT00879476

Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 Two subjects (subject numbers 01 and 06) were withdrawn from the study in period I and subject number 02 did not report for period II.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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ramipril 10mg capsules

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-01-01
• Completion: 2007-03-01
• First posted: 2009-04-10
• Last updated: 2009-04-10

Locations

1 site across 1 country: India