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Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR

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 and Pyrimethamine (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


This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group 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)


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.


Inclusion Criteria:

- healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg


- 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: June 2013
Last updated: October 27, 2013

Page last updated: August 20, 2015

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