Official Title: “Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-availability Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Dapagliflozin
  • Tablets, Oral, 10 mg, Single Dose
• Drug: Metformin XR
  • Tablets, Oral, 1000 mg, Single Dose
• Drug: Glucophage
  • Tablets, Oral, 1000 mg, Single Dose

Arms, Groups and Cohorts in this Clinical Trial

• Other: FDC of dapagliflozin/metformin XR
• Other: FDC of dapagliflozin/reduced mass metformin XR
• Other: dapagliflozin and Glucophage® XR

Primary Measures

• Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
  • Time Frame: 48 hours post-dose
    Safety Issue?: No

Secondary Measures

• Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)
  • Time Frame: 15 timepoints in 48 hours time interval
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Overall Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:  Clinical.Trials@bms.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01002807

Study ID Number: MB102-065

ClinicalTrials.gov Identifier: NCT01002807

Health Authority: United States: Food and Drug Administration

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