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OpenTrials
Completed

NCT Number: NCT00908271

Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

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

Primary outcomes

  1. Absolute oral bioavailability

    Time frame: Within the 3 days after study drug administration

Secondary outcomes

  1. Adverse events (AE)

    Time frame: Within the 3 days after study drug administration

  2. Vital signs

    Time frame: Within the 3 days after study drug administration

  3. Clinical safety labs

    Time frame: Within the 3 days after study drug administration

  4. Electrocardiograms (ECGs)

    Time frame: Within the 3 days after study drug administration

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 25, 2009
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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