UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038596 |
|---|---|
| Receipt number | R000043984 |
| Scientific Title | A pharmacokinetic study of Food containing plant extract-Open study- |
| Date of disclosure of the study information | 2019/11/16 |
| Last modified on | 2020/02/28 10:48:18 |
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Basic information
Public title
A pharmacokinetic study of Food containing plant extract-Open study-
Acronym
A pharmacokinetic study of Food containing plant extract
Scientific Title
A pharmacokinetic study of Food containing plant extract-Open study-
Scientific Title:Acronym
A pharmacokinetic study of Food containing plant extract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of plant extract-derived component
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of plant extract-derived component
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food (low dose)
Interventions/Control_2
Single ingestion of test food (high dose)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1)Subjects who are judged as unsuitable for the current study by the investigator through the screening tests.
(2)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(3)Subjects who take medications.
(4)Subjects who regularly take functional foods (including Food for Specified Health Uses or Foods with Function Claims).
(5)Subjects who have declared allergic reaction to ingredients of test foods.
(6)Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(7)Subjects who have a chronic disease and use medications continuously.
(8)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(9)Subjects who have had diarrhea within the last one week prior to the screening tests and/or who are prone to diarrhea.
(10)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Subjects who have a history of and/or contract drug addiction and/or alcoholism.
(12)Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(13)Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(14)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi, Maebashi-shi, Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Co., Ltd
Division name
Sales Department
Zip code
1050023
Address
7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
0334527733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Mona Grasse Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.jp
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 前橋北病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 16 | 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
30
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
| 2019 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 15 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043984
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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