Drug Interaction With Metformin
NCT00546741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2016-12-20
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
Conditions
- Healthy Male and Female Subjects
Interventions
- DRUG
-
Tablets, Oral, 20 mg, once daily single dose
- DRUG
-
Tablets, Oral, 1000 mg, once daily, single dose
- DRUG
-
Dapagliflozin + Metformin
Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2008-02-29
- Completion
- 2008-02-29
Countries
- United States
Study Locations
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