Healthy adult male subjects
Conditions
Interventions
Single administration of 20 mg tablet of simvastatin
Sponsors
Research Group of Global Clinical Study on Ethnic Differences in Drug Metabolism Based on the Announcement by the Japanese, Chinese and Korean Ministers of Health, Labor and Welfare
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Those who are capable of providing written informed consent. 2) Men aged 20 to 35 years at the time of signing informed consent. 3) BMI of 18.5 to <30.0 and body weight of 50.0 to 100.0 kg at screening. 4) Those who are determined by the investigator to be healthy in the screening test and eligible for the study.
Exclusion criteria
Exclusion criteria: 1)Organopathy involving the heart, lung, liver and/or kidney, etc. 2)A history of diseases involving the heart, lung, kidney, blood (such as coagulation system disorder), central nervous system and metabolic system that may interfere with the study. 3)Hypothyroidism, genetic myopathy or family history of it, history of drug-induced myopathy 4)Hypersensitivity or allergies to drugs, food, etc. (Particularly, a history of allergy to or adverse reactions associated with statin-type antihyperlipidemia drugs) 5)Oral administration of drugs such as over-the-counter drugs, health foods (supplements) that may affect metabolism of the test drug, grapefruit and drink/food including grapefruit within 1 week prior to the study drug administration, or taking drink including caffeine or green tea within 3 days prior to the study drug administration, or the necessity for using other medications before study completion. 6)Smokers or a smoking history within the last 6 months. (The cotinine test is performed, if necessary) 7)Drug abuse or suspicion of drug abuse. (The drug screening test is performed, if necessary) 8)Alcohol drinkers (daily alcohol intake of 50 g or more). 9)Total bilirubin or direct bilirubin is 1.5 times higher, AST, ALT and ALP is 2.5 times higher, or other liver and renal function tests items are 1.25 times higher than the upper limits of normal at the sites. The creatinine clearance (calculated by Cockcroft-Gault formula) is lower than the normal range at the sites. 10)Transfusion of 200 mL or more within 1 month prior to study drug administration, blood component donation (plasma or platelet) within 2 weeks, or blood collection of 400 mL or more within 3 months. 11)Those who are determined by the investigator to be not suitable as subjects of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of simvastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactShinichi Kawai
Toho University School of Medicine Division of Rheumatology, Department of Internal Medicine
Outcome results
None listed