UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics study of a food containing botanical extract - Randomized crossover study -
Acronym	Pharmacokinetics study of a food containing botanical extract
Scientific Title	Pharmacokinetics study o of a food containing botanical extract - Randomized crossover study -
Scientific Title:Acronym	Pharmacokinetics study of a food containing botanical extract
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the pharmacokinetics of functional food
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum observed plasma concentration, Maximum time plasma concentration, Area under the plasma concentration-time curve from time zero to the time of the last measurable drug concentration
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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of test food 1 -> Washout(1day) -> Single ingestion of test food 2
Interventions/Control_2	Single ingestion of test food 2 -> Washout(1day) -> Single ingestion of test food 1
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	39 years-old >=
Gender	Male
Key inclusion criteria	1)Males equal to or more than 20 years and less than 39 years of age 2)Subjects who BMI18.5=> kg/m2 and <30kg/m2 3)Subjects who visit on schedule days 4)Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1)Subjects who have systolic blood pressure <90 mmHg 2)Subjects who donated 200 mL or more of blood within 4 weeks from the start of the study 3)Subjects who donated 400 mL or more of blood within 12 weeeks from the start of the study 4)Subjects who donated 1200 mL over or more of blood within 12 months from the start of the study 5)Subjects who participated in other clinical studies in the past 4 weeks 6)Subjects who fall under any of the following items a) Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs b) Subjects who are under treatment or have a history of cardiovascular disease c) Subjects who develop diabetes d) Subjects who have allergy related to the study foods 7)Subjects who are under treatment 8)Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection 9)Subjects who have allergy related to the foods 10)Subjects who have experienced sickness due to blood collection 11)Subjects who have difficulty drawing blood from the peripheral vein 12)Heavy alcoholic beverager(40g alcohol/day>=) 13)Subjects who quit smoking for less than 6 months or smokers 14)Subjects whose eating habits are extremely irregular 15)Shift worker and night worker 16)Subjects who took medicine before the study 17)Subjects who use oral supplements which may affect this study 18)Subjects who the physician's judgement found difficult to consume the test foods 19)Subjects who are ineligible due to physician's judgement
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Hoshino
Organization	Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name	General Medicine Clinical Departments : Internal Medicine Respiratory Medicine Allergy
Zip code	003-0011
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL	011-868-2711
Email	n-abe@medi-ate.jp

Public contact
Name of contact person	1st name Toyotada Middle name Last name Ashino
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1405
Address	452-1 Toiso, Eniwa-shi, Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	t-ashino@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
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	Medical Corporation Jikokai Shiroishi Internal Medicine Clinic Clinical Trial Review Committee
Address	1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel	011-836-3531
Email	s-fukui@jikokai.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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 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	16
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	2021 Year 04 Month 20 Day
Date of IRB	2021 Year 04 Month 26 Day
Anticipated trial start date	2021 Year 05 Month 11 Day
Last follow-up date	2021 Year 05 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 28 Day
Last modified on	2022 Year 10 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050316