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CompletedPhase 1

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

An Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of a Tablet Formulation of Rosiglitazone XR (BRL-049653) 8mg Manufactured at Two Different Sites in Healthy Volunteers in Fasting Conditions

Lead sponsor

GlaxoSmithKline

Asset

Rosiglitazone

Listed sites

1

Recruiting sites

-

Enrollment

50

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-55

Primary endpoint

•PK samples

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAXR107453
NCT IDNCT00468897

Timeline

Milestones

Study start2007-03-21actual
Primary completion2007-05-02actual
Study completion2007-05-02actual
Study first posted2007-05-03estimated
Last update posted2017-08-07actual

Assets

Drug assets

Rosiglitazone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy male or female aged 18-55 years.
•BMI between 19 - 30 kg/m2

Exclusion criteria

•Liver function tests above the upper limit
•Excessive alcohol consumption history
•History of Cigarette smoking
•Positive HIV, Hep B or C test
•Positive pregnancy test
•History of heparin sensitivity
•History of glucose intolerance

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.

Time frame:Up to 32

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

PK samples

Time frame:at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.