Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR
Overview[ - collapse ][ - ]
Purpose | This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers. |
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Condition | Healthy |
Intervention | Drug: Metformin and Pyrimethamine |
Phase | Phase 1 |
Sponsor | Seoul National University Hospital |
Responsible Party | Seoul National University Hospital |
ClinicalTrials.gov Identifier | NCT01973933 |
First Received | October 27, 2013 |
Last Updated | October 27, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 27, 2013 |
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Last Updated Date | October 27, 2013 |
Start Date | June 2013 |
Estimated Primary Completion Date | Not Provided |
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 Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR |
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Official Title | A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Pyrimethamine and Metformin IR After Oral Administration in Healthy Male Volunteers |
Brief Summary | This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
Intervention | Drug: Metformin and Pyrimethamine Other Names:
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Study Arm (s) | Experimental: Metformin and Pyrimethamine Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8) |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 20 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | August 2013 |
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 | NCT01973933 |
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Other Study ID Numbers | MPI02 |
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 | October 2013 |
Locations[ + expand ][ + ]
Seoul National University Bundang Hospital | Seoul, Korea, Republic of |
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