Last updated: 11/03/2018 16:02:47

Avandamet Bioequivalence Study Brazil - Fed Administration

GSK study ID
114040
See study documents
Clinicaltrials.gov ID
NCT01332071
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessment of relative bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the form of film coated tablets versus Avandamet 2 mg + 500 mg (GSK) in the form of film coated tablets, in healthy volunteers after feeding standardized, using Liquid Chromatography.
Trial description: The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

AUC0-t of Rosiglitazone Maleate

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

Cmax of Rosiglitazone Maleate

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

AUC0-infinity of Rosiglitazone Maleate

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

AUC0-t of Metformin Hydrochloride

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

AUC0-infinity of Metformin Hydrochloride

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

Cmax of Metformin Hydrochloride

Timeframe: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg
  • Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
    • Enrollment:
    26
    Primary completion date:
    2009-06-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    metformin, rosiglitazone, rosiglitazone/metformin
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • EXCLUSION CRITERIA:
    • The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • EXCLUSION CRITERIA:
    • The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
    • History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug’s absorption, distribution, excretion or metabolism;
    • History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
    • Hypo or hypertension of any etiologic that needs pharmacologic treatment;
    • The results of the laboratory exams are out of the values considered as normal according this protocol’s rules, unless that they are considered as clinically irrelevant by the investigator;
    • Has history of alcohol or drugs abuse;
    • History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
    • Use of MAO inhibitors two weeks before the start of treatment;
    • Use of inhibitors of 5-TH reuptake,
    • Pregnancy or breastfeeding,
    • Smoking;
    • Use of regular medication within 4 weeks prior to study iniciation;
    • Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation. INCLUSION CRITERIA:
    • Age between 18 and 50 years;
    • Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
    • Good health conditions;
    • Obtain the Informed Consent’s signed.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Goiania, Goiás, Brazil
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-06-12
    Actual study completion date
    2009-06-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 114040 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website