Status:
COMPLETED
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00908271
Start Date
July 1 2009
End Date
August 1 2009
Last Update
October 17 2016
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704