NCT01973933

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 27, 2013

Last Update Submit

October 27, 2013

Conditions

Healthy

Keywords

MetforminPyrimethamineDrug interaction

Outcome Measures

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

    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)

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

Study Arms (1)

Metformin and Pyrimethamine

EXPERIMENTAL

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

Drug: Metformin and Pyrimethamine

Interventions

Metformin and PyrimethamineDRUG
Also known as: Diabex, Daraprim
Metformin and Pyrimethamine

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive)
  • kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

MetforminPyrimethamine

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jae-Yong Chung, MD, PhD

    Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 1, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

KR(1)