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

Overview[ - collapse ][ - ]

Purpose This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.
ConditionHealthy
InterventionDrug: Metformin and Pyrimethamine
PhasePhase 1
SponsorSeoul National University Hospital
Responsible PartySeoul National University Hospital
ClinicalTrials.gov IdentifierNCT01973933
First ReceivedOctober 27, 2013
Last UpdatedOctober 27, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 27, 2013
Last Updated DateOctober 27, 2013
Start DateJune 2013
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresAUC(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] [Designated as safety issue: No]AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
Current Secondary Outcome MeasuresAUG(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] [Designated as safety issue: No]AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Descriptive Information[ + expand ][ + ]

Brief TitleClinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR
Official TitleA 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
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignEndpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: Metformin and Pyrimethamine
Other Names:
  • Diabex
  • Daraprim
Study Arm (s)Experimental: Metformin and Pyrimethamine
Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment20
Estimated Completion DateNot Provided
Estimated Primary Completion DateAugust 2013
Eligibility Criteria
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.
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01973933
Other Study ID NumbersMPI02
Has Data Monitoring CommitteeNo
Information Provided BySeoul National University Hospital
Study SponsorSeoul National University Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
Verification DateOctober 2013

Locations[ + expand ][ + ]

Seoul National University Bundang Hospital
Seoul, Korea, Republic of