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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name