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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003702
Receipt No. R000004473
Scientific Title Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorption
Date of disclosure of the study information 2010/08/01
Last modified on 2010/09/08

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Basic information
Public title Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorption
Acronym Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorption
Scientific Title Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorption
Scientific Title:Acronym Drug - Food interaction of Oseltamivir(Tamiflu) in oral absorption
Region
Japan

Condition
Condition Influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 to confirm mechanism of oral absorption of Tamiflu in healthy male subjects
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes PK profiles of Oseltamivir and it's metabolite Ro64-0802 in plasma and urine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The Tamiflu capsule is taken with water.
Interventions/Control_2 The Tamiflu capsule is taken with milk.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >
Gender Male
Key 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.
Key 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
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuo Ogihara
Organization Takasaki University of Health and Welfare
Division name Faculty of Pharmacy,Department of Pharmaceutical Science ,Biopharmaceutics laboratory
Zip code
Address 60 Nakaoorui-machi,Takasaki-shi,Gunma-ken
TEL 027-352-1180(ext.8311)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Inano
Organization Neues Corporation
Division name Clinical research support
Zip code
Address 6-18,Tenya machi Hakata-ku,Fukuoka-City
TEL 092-283-7100
Homepage URL
Email inano.akihiro@neues.co.jp

Sponsor
Institute Takuo Ogihara
Institute
Department

Funding Source
Organization Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Medical corporation LTA Sumida Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人 相生会 墨田病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 03 Day
Last modified on
2010 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004473

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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