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CompletedNCT01973933Updated Nov 1, 2013

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

A Phase 1 interventional study of Metformin and Pyrimethamine in Healthy, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Metformin
  • Pyrimethamine
  • Drug interaction
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Metformin and Pyrimethamine

    Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)

    Drug: Metformin and Pyrimethamine

Interventions

  • DrugMetformin and Pyrimethamine

    Also known as: Diabex, Daraprim

06

What researchers measure

Primary outcomes

  1. AUC(area under the plasma concentration-time curve)

    AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

    Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary outcomes

  1. AUG(total area under the serum concentration-time curve for glucose)

    AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

    Time frame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01973933
Lead sponsor
Seoul National University Hospital
Responsible party
Jae Yong Chung (Assistant Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Nov 1, 2013
Start date
Jun 2013
Primary completion
Aug 2013
Last update
Nov 1, 2013

Study contacts

Jae-Yong Chung, MD, PhD
principal investigator · Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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