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
Summary
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)
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: June 2013
Last updated: October 27, 2013
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