Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

Criteria

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