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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin and Pyrimethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01973933

MPI02

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Metformin and Pyrimethamine

Experimental group

Description:

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

Treatment:

Drug: Metformin and Pyrimethamine