Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

NCT ID: NCT00908271

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Dapagliflozin

PO and IV

Group Type OTHER

Dapagliflozin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MB102-059

Identifier Type: -

Identifier Source: org_study_id

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