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Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorptio

Phase 1
Conditions
Influenza
Registration Number
JPRN-UMIN000003702
Lead Sponsor
Takuo Ogihara
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Male
Target Recruitment
6
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PK profiles of Oseltamivir and it's metabolite Ro64-0802 in plasma and urine
Secondary Outcome Measures
NameTimeMethod
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