Healthy volunteers (Japanese male)
Conditions
Interventions
baseline (day0), day 1 Drug administration (semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) ->
Drug administration(clinical dose of rifampicin (150 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) ->
Drug administration(clinical dose of rifampicin (300 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)->
Drug administration(clinical dose of rifampicin (600 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)
baseline (day0), day 1 Drug administration (semi-pha
Drug administration(clinical dose of rifampicin (300 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin) ->
Drug administration(clinical dose of rifampicin (150 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)->
Drug administration(clinical dose of rifampicin (600 mg), and semi-pharmacological dose of atorvastatin, valsartan, pitavastatin, and rosuvastatin)
Sponsors
P-One Clinic,Keikokai Medical Corp.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) Japanese male subjects at the age of 20-40 at the timing of informed consent b) Person who is judged as an appropriate subject for this clinical study by doctors based on the previous medical history and the results of clinical test at the screening c) BMI of subject should be in the range of 18.5 and 25 at the screening. d) person who can understand and follow the clinical study plan and give us a written informed consent based on the free will
Exclusion criteria
Exclusion criteria: 1.a history of hypersensitivity to atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin 2.lactose intolerance 3.hypotension (systolic blood pressure <90 mmHg) or hypertension (systolic blood pressure >160 mmHg) 4.donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs 5.a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia 6.known to have Gilberts Disease, and/or Rotor syndrome 7.confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator 8.a clinically severe disease within 30 days before administration of study drugs 9.took drugs, health food including St. Johns wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study 10.smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period 11.took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with prohibition of taking them until the day of discharge in each study period 12.tested positive in an alcohol breath test/urine drug test at screening 13.cannot discontinue the use of drugs other than study drugs from 2 weeks before administration of study drugs until the study completion 14.positive to HBs antigens, HCV antibodies, or HIV antigens/antibodies 15.judged inappropriate by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of coproporphyrins, total and direct bilirubin, bile acids (including glucuronide and sulfate conjugates), and 7a-hydroxy-4-cholesten-3-one, effect of the administration of rifampicin Plasma concentrations of atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin, and their metabolites, effect of the coadministration of rifampicin, pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of genetic polymorphisms of OATP1B1 and other transporters and metabolizing enzymes related to the disposition of the probe drugs and endogenous substrates | — |
Countries
Japan
Contacts
Public ContactHiroyuki Kusuhara
The University of Tokyo Graduate School of Pharmaceutical Sciences
Outcome results
None listed