Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Overview[ - collapse ][ - ]
Purpose | This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men. |
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Condition | Healthy |
Intervention | Drug: Metformin Drug: Metformin and Pantoprazole Drug: Metformin and Rabeprazole |
Phase | Phase 1 |
Sponsor | Seoul National University Hospital |
Responsible Party | Seoul National University Hospital |
ClinicalTrials.gov Identifier | NCT01857609 |
First Received | May 10, 2013 |
Last Updated | May 15, 2013 |
Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 10, 2013 |
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Last Updated Date | May 15, 2013 |
Start Date | August 2012 |
Estimated Primary Completion Date | December 2012 |
Current Primary Outcome Measures | AUC(area under the plasma concentration-time curve) [Time Frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose] [Designated as safety issue: No]AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2 |
Current Secondary Outcome Measures | AUG(total area under the serum concentration-time curve for glucose) [Time Frame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test] [Designated as safety issue: No]AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration) |
Descriptive Information[ + expand ][ + ]
Brief Title | Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin |
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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. |
Brief Summary | This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
Intervention | Drug: Metformin Other Names: DiabexDrug: Metformin and Pantoprazole Other Names: Diabex, PantolocDrug: Metformin and Rabeprazole Other Names: Diabex, Pariet |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 24 |
Estimated Completion Date | December 2012 |
Estimated Primary Completion Date | December 2012 |
Eligibility 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. |
Gender | Male |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01857609 |
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Other Study ID Numbers | MPI |
Has Data Monitoring Committee | No |
Information Provided By | Seoul National University Hospital |
Study Sponsor | Seoul National University Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea |
Verification Date | May 2013 |
Locations[ + expand ][ + ]
Seoul National University Bundang Hospital | Seoul,, Korea, Republic of |
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