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

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ClinicalTrials.gov Identifier: NCT01973933
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Metformin and Pyrimethamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973933


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

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Responsible Party: Jae Yong Chung, Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01973933     History of Changes
Other Study ID Numbers: MPI02
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Jae Yong Chung, Seoul National University Bundang Hospital:
Metformin
Pyrimethamine
Drug interaction

Additional relevant MeSH terms:
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Metformin
Pyrimethamine
Hypoglycemic Agents
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action