healthy male subjects
Conditions
Interventions
four terms Phase 1(washout 1week)-phase2(washout 3weeks)-phase3(washout 1week)-phase4 phase1 metformin(MD) Phase2 metformin(MD) and pyrimethamine Phase3 metformin(CD) Phase4 metformin(CD) an
Sponsors
Clinical trial Center,Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Ability to understand and willing to sign the informed consent. 2) Japanese healthy male subjects age 20 to 35 years of age 3) Body Mass Index (BMI):18.5~28.5 4) good health as determined by physical examination, vital signs and laboratory tests.
Exclusion criteria
Exclusion criteria: 1) Any medical condition that requires medical attention 2) Impairments of liver or kidney functions 3) Dysemia and history of this disease 4) Cardiac disease or respiratory disease and history of them 5) Any hypersensitivity to pyrimethamine or metformin 6) Use of medicine or health product including Saint John's wort 2 weeks before pre-dose. 7) Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose. 8) Participation to any other clinical research in the past 3 months. 9)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months. 10) Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody. 11) Any allergy to drug and food 12) history of drug or alcohol abuse 13) Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters in plasma | — |
Countries
Japan
Outcome results
None listed