Drug Interaction With Metformin

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Metformin

Criteria

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