Influenza
Conditions
Interventions
The Tamiflu capsule is taken with water.
The Tamiflu capsule is taken with milk.
Sponsors
Takuo Ogihara
Medical corporation LTA Sumida Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: the investigators must ensure that all subjects being considered to meet the following inclusion criteria: 1) healthy male who is capable to understand and sign the informed consent. 2) male between 20 and <45 years of age on the day of signing informed consent 3)Body Mass Indes(BMI) between 17.6 and 26.4 kg/m2 inclusive 4)good health as determined by physical examination and laboratory tests etc.
Exclusion criteria
Exclusion criteria: the investigators must ensure that all subjects being considered to meet the following exclusion criteria or conditions: 1)history of allergy to Oseltamivir 2)difficult to take milk because of lactose intolerance etc. 3)disease thought to be decreased metabolic function of liver(acute hepatitis,chronic hepatitis,hepatic cirrhosis,liver carcinoma,jaundice) 4)decreased metabolic function of kidney 5)electrocardiogram (ECG) showing a QTc>460 msec 6)who take any drugs or supplement including St.John's wort within a week prior to test drug administration 7)fruit juice including grapefruit, orange or apple within 7 days prior to test drug administration 8)recent (past 3 months) participation in other clinical trial for investigational agent,the investigator determines this trial participation inadequate 9)donation of 400mL or more of blood within 3 months prior to participation, donation of 200mL or more of blood within 1 month prior to participation 10)any positive results of HBs-AG,HCV-AB,HIV AB,HIV AG,TPHA. 11)history of allergy to any medicines and foods 12)history of drug or alcohol abusement 13) the investigator determines inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK profiles of Oseltamivir and it's metabolite Ro64-0802 in plasma and urine | — |
Countries
Japan
Contacts
Public ContactAkihiro Inano
Neues Corporation Clinical research support
Outcome results
None listed