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Completed

NCT Number: NCT00546741

Drug Interaction With Metformin

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

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Key information

Conditions

Healthy Male and Female Subjects Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, 08690, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion criteria

  • Unwilling to use acceptable method of birth control
  • current or recent (within 1 month) smoker
  • abnormal liver function tests
  • presence of edema
  • history of diabetes mellitus
  • history of heart failure or renal insufficiency
  • history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
  • history of Hepatitis C

Treatment and study plan

Dapagliflozin

Drug

Tablets, Oral, 20 mg, once daily single dose

metformin

Drug

Tablets, Oral, 1000 mg, once daily, single dose

Dapagliflozin + Metformin

Drug

Tablets, Oral, once daily, single dose

Dapagliflozin: 20 mg

Metformin: 1000 mg

Primary outcomes

  1. To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment

    Time frame: measures taken daily throughout the study

Secondary outcomes

  1. To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment

    Time frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 19, 2007
Registry last updated
Dec 20, 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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