UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034637 |
|---|---|
| Receipt number | R000039493 |
| Scientific Title | A pharmacokinetics study of the major ingredient and its metabolites after multiple ingestions of test food |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2018/11/29 12:01:33 |
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Basic information
Public title
A pharmacokinetics study of the major ingredient and its metabolites after multiple ingestions of test food
Acronym
A pharmacokinetics study of food ingredients
Scientific Title
A pharmacokinetics study of the major ingredient and its metabolites after multiple ingestions of test food
Scientific Title:Acronym
A pharmacokinetics study of food ingredients
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for the pharmacokinetics of food ingredients
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cmax
Tmax
AUC
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
Oral intake of the test food for 5 days (3 times a day, 13 times in all)
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Age: 30 and over, below 60.
2) Sex: Japanese males
3) Understanding the study intent and purpose and submitting the written informed consent before study.
4) Subjects who are negative for HBs antigen/antibody, HCV antibody, HIV antigen/antibody, syphilis antigen tests.
Key exclusion criteria
1) Subjects who are in a continuing treatment with a prescription drug for over a month.
2) Subjects who intake of a prescription drug or an over-the-counter drug within a last week.
3) Subjects who does not meet the following clinical testing criteria; AST and ALT below 30 U/L, gamma-GTP below 50 U/L.
4) Subjects who are deemed to be unsuitable by the physician- in-charge.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Takehara |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
Consumer Products Planning Department
Zip code
Address
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
TEL
+81-3-3946-1112
Masaaki_Takehara@mail.zenyaku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagata |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
Consumer Products Planning Section, Consumer Products Planning Department
Zip code
Address
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
TEL
+81-3-3946-1112
Homepage URL
Takeshi_Nagata@mail.zenyaku.co.jp
Sponsor or person
Institute
Zenyaku Kogyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
HUMA R&D CORP
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
とうきょうスカイツリー駅前内科（東京都）/Tokyo Skytree Station Medical Clinic (Tokyo)、全薬工業株式会社研究開発センター（東京都）/Zenyaku Kogyo Research and Develop Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 26 | 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
| 2018 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 29 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039493
