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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023907
Receipt No. R000027530
Scientific Title Bioequivalence study of food
Date of disclosure of the study information 2016/09/05
Last modified on 2017/02/15

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Basic information
Public title Bioequivalence study of food
Acronym Bioequivalence study of food
Scientific Title Bioequivalence study of food
Scientific Title:Acronym Bioequivalence study of food
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the bioequivalence of foods
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cmax
AUC(0-24h)
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of test food 1->Washout (5 days or more)->Single ingestion of test food 2->Washout (5 days or more)->Single ingestion of test food 3
Interventions/Control_2 Single ingestion of test food 2->Washout (5 days or more)->Single ingestion of test food 3->Washout (5 days or more)->Single ingestion of test food 1
Interventions/Control_3 Single ingestion of test food 3->Washout (5 days or more)->Single ingestion of test food 1->Washout (5 days or more)->Single ingestion of test food 2
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
49 years-old >=
Gender Male
Key inclusion criteria (1)Males whose age are 20<= years old <= 49
(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 or HIV antigen/antibody test
(6)Subjects who are deemed to be unsuitable by the investigator
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Nakamura
Organization Suntory Business Expert Limited
Division name R&D Support Division HE Center
Zip code
Address 2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL 03-5579-1277
Email Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Yoshimura
Organization Suntory Business Expert Limited
Division name R&D Support Division HE Center
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0535
Homepage URL
Email Makiko_Yoshimura@suntory.co.jp

Sponsor
Institute Suntory Business Expert Limited
Institute
Department

Funding Source
Organization None
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
2016 Year 09 Month 05 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
2016 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 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
2016 Year 09 Month 02 Day
Last modified on
2017 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027530

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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