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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States, 53704