UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pharmacokinetics study of the major ingredient and its metabolites after multiple ingestions of test food
Title of the study (Brief title)	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	Masaaki Takehara
Organization	Zenyaku Kogyo Co., Ltd.
Division name	Consumer Products Planning Department
Address	6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
TEL	+81-3-3946-1112
Email	Masaaki_Takehara@mail.zenyaku.co.jp

Public contact
Name of contact person	Takeshi Nagata
Organization	Zenyaku Kogyo Co., Ltd.
Division name	Consumer Products Planning Section, Consumer Products Planning Department
Address	6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
TEL	+81-3-3946-1112
Homepage URL
Email	Takeshi_Nagata@mail.zenyaku.co.jp

Sponsor
Institute	Zenyaku Kogyo Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039493