Drug Interaction With Metformin

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

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