healthy male subjects
Conditions
Interventions
Drug administration(microdose of atorvastatin,midazolam,pravastatin)->
(over 1week for washout)->
Drug administration(clinical dose of rifampicin,microdose of atorvastatin, midazolam,pravastatin)->
Drug administration(clinical dose of itraconazole,microdose of atorvasutatin, midazolam, pravastatin)
Sponsors
Clinical trial Center,Kitsato 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 40 years of age 3)Weight between 50-100kg. 4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
Exclusion criteria
Exclusion criteria: 1)Any hypersensitivities to atorvastatin,midazolam,pravastatin, straconazole or rifampicin. 2)hepatic disease requiring treatment. 3)acute narrow-angle glaucoma 4)QT prolongation over 460ms. 5)Use of medicine or health product including Saint John's wort 2 weeks before pre-dose. 6)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose. 7)Participation to any other clinical reseach in the past 3 months. 8)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months. 9)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody. 10)Any allergy to drug and food 11)Drug abuse or positive drug screening 12)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic of atorvastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics of midazolam, pravastatin, itraconazole and rifampicin gene analysis | — |
Countries
Japan
Outcome results
None listed