Drug Interaction With Metformin
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes
Intervention: Dapagliflozin (Drug); Metformin (Drug); Dapagliflozin + Metformin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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
Clinical Details
Official title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
Study design: Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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
Secondary outcome: To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey 08690, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2007
Ending date: February 2008
Last updated: May 15, 2008
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