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Drug Interaction With Metformin

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ClinicalTrials.gov Identifier: NCT00546741
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Male and Female Subjects Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin + Metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
Study Start Date : November 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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





Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00546741     History of Changes
Other Study ID Numbers: MB102-026
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016

Keywords provided by AstraZeneca:
Diabetes,NOS

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