NCT00863915

A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product Atlace® manufactured by Monarch Pharmaceuticals Inc. administrated as a sprinkle on one tablespoonful of applesauce to healthy subjects after a 10-hour overnight fast

Detailed description

Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Administered Orally as a Sprinkle on Applesauce Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ramipril10 mg Capsules, single dose	A: Experimental Subjects received Purepac formulated products sprinkled on one tablespoonful of applesauce
DRUG	Atlace® 10 mg capsules, single dose	B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products sprinkled on one tablespoonful of applesauce

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States