Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Metformin (Drug); Metformin and Pantoprazole (Drug); Metformin and Rabeprazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Jae-Yong Chung, MD, PhD, Principal Investigator, Affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
Summary
This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics
and pharmacodynamics of metformin in healthy Korean men.
Clinical Details
Official title: The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC(area under the plasma concentration-time curve)
Secondary outcome: AUG(total area under the serum concentration-time curve for glucose)
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Seoul National University Bundang Hospital, Seoul,, Korea, Republic of
Additional Information
Starting date: August 2012
Last updated: May 15, 2013
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