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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01973933

Enrollment

Registered

2013-11-01

Start date

2013-06-30

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Metformin, Pyrimethamine, Drug interaction

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.

Interventions

DRUGMetformin and Pyrimethamine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
AUC(area under the plasma concentration-time curve)	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose	AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

Secondary

Measure	Time frame	Description
AUG(total area under the serum concentration-time curve for glucose)	predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test	AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026