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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034092
Receipt No. R000038866
Scientific Title Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY)
Date of disclosure of the study information 2018/09/12
Last modified on 2019/05/22

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Basic information
Public title Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY)
Acronym Pharmacokinetics study of food ingredient.
Scientific Title Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY)
Scientific Title:Acronym Pharmacokinetics study of food ingredient.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the pharmacokinetics of food ingredient.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes t1/2
Cmax
Tmax
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of test food
Interventions/Control_2
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (1)Healthy male and female whose age are 40 <= years old <70.
(2)Subjects who are able to submit the written informed consents.
Key exclusion criteria (1)Subjects who are with treatment.

(2)Subjects who are with history of gastrointestinal surgery.

(3)Subjects who are attending other studies or attended other studies within the past 4 weeks.
(4)Subjects who are;
a)With present heart disorder, liver disorder, or kidney disorder,
b)With history of cardiac disorder,
c)With diabetes mellitus, or
d)With allergy to the study foods.
(5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody, HIV antigen/antibody or HTLV-1 antibody test.
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Teramoto
Organization Suntory Beverage & Food Limited
Division name Development and Design Department
Zip code
Address 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL 050-3182-6114
Email Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Kanzaki
Organization Suntory Beverage & Food Limited
Division name Development and Design Department
Zip code
Address 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL 050-3182-0666
Homepage URL
Email Noriyuki_Kanzaki@suntory.co.jp

Sponsor
Institute Suntory Beverage & Food Limited
Institute
Department

Funding Source
Organization Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 12
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
2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038866

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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