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

NCT00863915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-16

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel V. Freeland,, D.O., CCI · CEDRA Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00863915 on ClinicalTrials.gov