NCT01973933CompletedPhase 1
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
Seoul National University Hospital1 site in 1 country20 target enrollmentStarted: June 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- AUC(area under the plasma concentration-time curve)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Metformin and Pyrimethamine
Experimental
Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)
Intervention: Metformin and Pyrimethamine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Jae Yong Chung
Assistant Professor
Seoul National University Bundang Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy VolunteersRheumatoid ArthritisNCT05392127Jiangsu HengRui Medicine Co., Ltd.24
Completed
Phase 1
GLS4/RTV and TAF Drug-drug InteractionChronic Hepatitis BNCT04551261Sunshine Lake Pharma Co., Ltd.28
Completed
Phase 2
Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLIActivated PI3K-delta SyndromeNCT02593539GlaxoSmithKline5
Completed
Phase 1
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.HIVAIDSOral ContraceptiveNCT00739622Tibotec Pharmaceuticals, Ireland18
Completed
Early Phase 1
Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT05891119Amgen21