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A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Fasting Conditions

NCT00865891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets 60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg tablet) in healthy adult volunteers under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Nifedipine Extended Release tablets 60 mg, single dose

A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under fasting conditions

DRUG

ADALAT® CC Extended Release Tablets 60 mg

B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm.D, · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2005-07-31
Completion
2005-07-31

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 NCT00865891 on ClinicalTrials.gov