Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
- Registration Number
- NCT01068756
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy subjects
- Body Mass Index (BMI) of 18 to 32 inclusive
- Women who are not of childbearing potential and men, ages 18 to 45
Exclusion Criteria
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
- Glucosuria
- Abnormal liver function tests
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dapagliflozin/Rifampin Dapagliflozin - Dapagliflozin/Rifampin Rifampin -
- Primary Outcome Measures
Name Time Method AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data Days 1 to 3 and Days 9 to 11
- Secondary Outcome Measures
Name Time Method Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data Days 1 to 3 and Days 9 to 11 Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data Days 1 to 3 and Days 9 to 11
Trial Locations
- Locations (1)
Ppd Development
🇺🇸Austin, Texas, United States