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Drug Interaction With Metformin

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00546741
First received: October 18, 2007
Last updated: December 19, 2016
Last verified: December 2016
  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
Healthy Male and Female Subjects
Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin + Metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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 AstraZeneca:

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 ]

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) ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00546741     History of Changes
Other Study ID Numbers: MB102-026
Study First Received: October 18, 2007
Last Updated: December 19, 2016

Keywords provided by AstraZeneca:
Diabetes,NOS

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2017