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A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Non-fasting Conditions

NCT00864149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-08-16

No results posted yet for this study

Summary

To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Carvedilol 12.5 mg Tablets, single dose

A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions

DRUG

Coreg® 12.5 mg Tablets , single dose

B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fed conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Y. Tam,, M.D · Biovail Contract Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Canada

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 NCT00864149 on ClinicalTrials.gov