Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Study identifier:MB102-059

ClinicalTrials.gov identifier:NCT00908271

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Jul 2009

Primary Completion Date: 01 Aug 2009

Study Completion Date: 01 Aug 2009

Study design

Allocation: N/A
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Covance Clinical Research Unit, Inc.

Madison, WI, United States, 53704

Arms	Assigned Interventions
Other: 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

"There is no result for the study"

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102-059_redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Covance Clinical Research Unit, Inc.

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MB102-059_redacted _CSR _synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator