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

October 27, 2013 updated by: Jae Yong Chung, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin and Pyrimethamine
Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)
Drug: Metformin and Pyrimethamine
Other Names:
  • Diabex
  • Daraprim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC(area under the plasma concentration-time curve)
Time Frame: 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
Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Yong Chung, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

October 27, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 27, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPI02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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