UMIN-CTR Clinical Trial

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
Email	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
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Co., Ltd
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043984