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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00546741 |
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Date of registration:
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18/10/2007 |
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Primary sponsor: |
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Public title:
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Drug Interaction With Metformin
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Scientific title:
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Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00546741 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Intervention(s)
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Drug: Dapagliflozin
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Drug: Dapagliflozin + Metformin
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Drug: Metformin
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Secondary ID(s)
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MB102-026
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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