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Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908271
First Posted: May 25, 2009
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute oral bioavailability [ Time Frame: Within the 3 days after study drug administration ]

Secondary Outcome Measures:
  • Adverse events (AE) [ Time Frame: Within the 3 days after study drug administration ]
  • Vital signs [ Time Frame: Within the 3 days after study drug administration ]
  • Clinical safety labs [ Time Frame: Within the 3 days after study drug administration ]
  • Electrocardiograms (ECGs) [ Time Frame: Within the 3 days after study drug administration ]

Enrollment: 7
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dapagliflozin
PO and IV
Drug: Dapagliflozin
Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908271


Locations
United States, Wisconsin
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00908271     History of Changes
Other Study ID Numbers: MB102-059
First Submitted: May 22, 2009
First Posted: May 25, 2009
Last Update Posted: October 17, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases