Japanese healthy subjects
Conditions
Interventions
The subjects will be administered a single-dose 75 mg of Oseltamivir once.
Sponsors
Oita University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years of age or older. 2) BMI between 18 and 30 kg/m2. 3) Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period. 4) Subjects must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(Ro64-0802) | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Oseltamivir), Cmax, C 12h, CL/f , Vd/f , tmax, t1/2, MRT (Oseltamivir and Ro64-0802), VAS | — |
Countries
Japan
Contacts
Public ContactYuki SUZAKI
Oita University Hospital General Clinical Research Center
Outcome results
None listed