Drug Interaction With Metformin

Completed · Phase 1

Conditions studied: Healthy Male and Female Subjects

In brief

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

Key facts

Study ID

NCT00546741

Run by

AstraZeneca

People needed

18

Starts

2007-11-01

Expected to finish

2008-02-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Bristol-Myers Squibb Clinical Pharmacology Unit — Hamilton, New Jersey, United States

Full record on ClinicalTrials.gov

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