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A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.

NCT00468897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-07

No results posted yet for this study

Summary

The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers

Conditions

Interventions

DRUG

RSG XR

RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-03-21
Primary Completion
2007-05-02
Completion
2007-05-02

Countries

  • Germany

Study Locations

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Diseases
Companies

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 NCT00468897 on ClinicalTrials.gov