UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003702 |
|---|---|
| Receipt number | 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 11:02:31 |
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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)
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
inano.akihiro@neues.co.jp
Sponsor or person
Institute
Takuo Ogihara
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004473
