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A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions

2014-08-27 03:23:31 | BioPortfolio

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 to healthy subjects after a 10-hour overnight fast

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 Under Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Ramipril10 mg Capsules, single dose, Atlace® 10 mg capsules, single dose

Location

CEDRA Clinical Research, LLC
Austin
Texas
United States
78759

Status

Completed

Source

Actavis Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:31-0400

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