Status:
COMPLETED
Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Lead Sponsor:
Seoul National University Hospital
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.
Eligibility Criteria
Inclusion
- healthy male subject aged 20 to 45 at screening
- A body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body weight range of +- 25%
- subjects who decide to participate voluntarily and write a informed consent form
Exclusion
- subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- Subject judged not eligible for study participation by investigator.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01857609
Start Date
August 1 2012
End Date
December 1 2012
Last Update
May 20 2013
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seoul, South Korea