Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
- Registration Number
- NCT00908271
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
Inclusion Criteria
- Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
Exclusion Criteria
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
- Exposure to significant radiation within 12 months prior to admission to the clinical facility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dapagliflozin Dapagliflozin PO and IV
- Primary Outcome Measures
Name Time Method Absolute oral bioavailability Within the 3 days after study drug administration
- Secondary Outcome Measures
Name Time Method Adverse events (AE) Within the 3 days after study drug administration Vital signs Within the 3 days after study drug administration Clinical safety labs Within the 3 days after study drug administration Electrocardiograms (ECGs) Within the 3 days after study drug administration
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Madison, Wisconsin, United States