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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metformin and Pyrimethamine

• Registration Number: NCT01973933
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-27
• Study First Submitted QC: 2013-10-27
• Last Update Submitted: 2013-10-27
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin and Pyrimethamine	Metformin and Pyrimethamine	Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of