Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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FDC of dapagliflozin/metformin XR

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, Single Dose

Metformin XR

Intervention Type DRUG

Tablets, Oral, 1000 mg, Single Dose

FDC of dapagliflozin/reduced mass metformin XR

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, Single Dose

Metformin XR

Intervention Type DRUG

Tablets, Oral, 1000 mg, Single Dose

dapagliflozin and Glucophage® XR

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, Single Dose

Glucophage

Intervention Type DRUG

Tablets, Oral, 1000 mg, Single Dose

Interventions

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Dapagliflozin

Tablets, Oral, 10 mg, Single Dose

Intervention Type DRUG

Metformin XR

Tablets, Oral, 1000 mg, Single Dose

Intervention Type DRUG

Glucophage

Tablets, Oral, 1000 mg, Single Dose

Intervention Type DRUG

Other Intervention Names

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Glucophage™

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 18 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

Exclusion Criteria

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Glucosuria at screening
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* Presence of edema on physical exam
* History of diabetes mellitus
* History of heart failure
* History of renal insufficiency
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
* Estimated creatinine clearance (ClCR) of \< 80 mL/min using the Cockcroft Gault formula
* History of allergy or intolerance to metformin or other similar agents

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes