healthy male volunteers
Conditions
Interventions
Tien-cha ingection
water ingestion
Sponsors
Second Department of Pharmacology, Showa University, School of Medicine
Medical Corporation Keiyu-Kai Group, Obara Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.written informed consent 2.age 20<= <40 (on screening day) 3.male 4.BMI(Body Mass Index):18.5-25.0
Exclusion criteria
Exclusion criteria: 1.Any present status or medical history of circulatory system, respiratory system, digestive system, hemotogeneous system and renal function or hepatic function disorder 2.Any drug allergy history 3.Drug abuse, alcoholic abuse 4.Smoking habit 5.Participation in any clinical trial within 4 months 6.Collected blood more than 200mL within 3 months 7.Tien-cha ingestion in the 2 weeks prior to study drug administration 8.Grape fruits juice ingestion in the 2 weeks prior to study drug administration 9.Any use of St Johns wart in the 2 weeks prior to study drug administration 10.Any use of drugs including OTCs in the 2 weeks prior to study drug administration 11.Any clinically significant abnormalities on the results of screening examination which was conducted in 4 the weeks prior to study drug administration 12.Any clinically significant abnormalities on the examination which was conducted before study drug administration 13.Any use of prescribed medicines 14.Any presence or family history of inherited muscle disease (such as muscular dystrophy) 15.Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC, Cmax of plasma simvastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, t1/2, CL/F of plasma simvastatin and safety assessment | — |
Countries
Japan
Contacts
Public ContactNaoki UCHIDA, MD, PhD
Showa University, School of Medicine Second Department of Pharmacology
Outcome results
None listed