The effect of CES1A genetic polymorphism on the pharmacokinetics of Oseltamivir
- Conditions
- Japanese healthy subjects
- Registration Number
- JPRN-UMIN000003774
- Lead Sponsor
- Oita University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1)The disease to need continuous medical treatment. 2)The liver and renal dysfunction and the psychic disease 3)Screening test results likely to show inappropriateness for participation in this study. 4)Febrile illness within 1 week before the first drug administration. 5)Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies. 6)Use of any ethical drug medication within 1 week before the first drug administration. 7)Consumption of the grapefruit-containing beverages within 1 week before the first drug administration. 8)Consumption of the St. Jone's Wirt-containing supplement within 1 week before the first drug administration. 9)Consumption of the cigarettes within 1 week before the first drug administration. 10)Pregnancy or lactation in women. 11)Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration. 12)Blood donation of 400 mL of whole blood within 3 months or 200 mL of whole blood within 1 month or blood components (plasma and platelet) within 2 weeks before the first drug administration. 13)Any others judged by the investigators to be inappropriate for the subject of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC(Ro64-0802)
- Secondary Outcome Measures
Name Time Method AUC (Oseltamivir), Cmax, C 12h, CL/f , Vd/f , tmax, t1/2, MRT (Oseltamivir and Ro64-0802), VAS