Official Title: “Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects”

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Dapagliflozin
  • Tablets, Oral, 20 mg, once daily single dose
• Drug: Metformin
  • Tablets, Oral, 1000 mg, once daily, single dose
• Drug: Dapagliflozin + Metformin
  • Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3

Primary Measures

• To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
  • Time Frame: measures taken daily throughout the study
    Safety Issue?: No

Secondary Measures

• To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
  • Time Frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

• Unwilling to use acceptable method of birth control
• current or recent (within 1 month) smoker
• abnormal liver function tests
• presence of edema
• history of diabetes mellitus
• history of heart failure or renal insufficiency
• history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
• history of Hepatitis C

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546741

Study ID Number: MB102-026

ClinicalTrials.gov Identifier: NCT00546741

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

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