Drug Interaction With Metformin

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546741
First received: October 18, 2007
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Diabetes
Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin + Metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dapagliflozin
Tablets, Oral, 20 mg, once daily single dose
Active Comparator: 2 Drug: Metformin
Tablets, Oral, 1000 mg, once daily, single dose
Active Comparator: 3 Drug: Dapagliflozin + Metformin

Tablets, Oral, once daily, single dose

Dapagliflozin: 20 mg

Metformin: 1000 mg


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546741

Locations
United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546741     History of Changes
Other Study ID Numbers: MB102-026
Study First Received: October 18, 2007
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Diabetes,NOS

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014