UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029771 |
|---|---|
| Receipt number | R000034009 |
| Scientific Title | Bioequivalence study of food |
| Date of disclosure of the study information | 2017/11/05 |
| Last modified on | 2018/05/02 09:05:27 |
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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
PK,PD
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
4
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-> Washout (5 days or more) -> Single ingestion of test food 4.
Interventions/Control_2
Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3.
Interventions/Control_3
Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 4 -> 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
Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1.
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 MONOZUKURI EXPERT LIMITED
Division name
R&D Support Department HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
03-5579-1277
Junichi_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Obata |
Organization
SUNTORY MONOZUKURI EXPERT LIMITED
Division name
R&D Support Department HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL
03-5579-1277
Homepage URL
Hidenori_Obata@suntory.co.jp
Sponsor or person
Institute
SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | 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
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | 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
| 2017 | Year | 10 | Month | 31 | Day |
Last modified on
| 2018 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034009
