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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000019387
Receipt No. R000022422
Scientific Title Pharmacokinetics of active ingredients by the intake of the functional food in healthy subjects
Date of disclosure of the study information 2016/10/27
Last modified on 2016/02/03

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Basic information
Public title Pharmacokinetics of active ingredients by the intake of the functional food in healthy subjects
Acronym Pharmacokinetics of active ingredients by the intake of the functional food
Scientific Title Pharmacokinetics of active ingredients by the intake of the functional food in healthy subjects
Scientific Title:Acronym Pharmacokinetics of active ingredients by the intake of the functional food
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study to evaluate the pharmacokinetics of active ingredients by the intake of the functional food in healthy subjects
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cmax, Tmax
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 Single ingestion of the functional food
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male
Key inclusion criteria Healthy adult males from 20 to 50 years of age
Key exclusion criteria (1) Those who are gastrointestinal diseases and history (except the appendicitis)
(2) Those who are judged as inappropriate for the study based on the results of clinical examination and cardiopulmonary function by the investigator
(3) Those who have diseases such as diabetes, a liver disease, kidney disease, gastrointestinal disease, serious heart disease, skin disease, and diseases affecting the secretion of sex disease in the past or present, or have history
(4) Those who take the prescription drug (including external medicine)
(5) Those who might be liable to allergy related to the study (ex. food allergy)
(6) Those who participates in other clinical study at the start of the study or are planned to participate in other clinical study during the study
(7) Those who exceed donation criteria of the Japanese Red Cross within one year from the date of informed consent for the study
(8) Those who are judged as unsuitable for the study based on the results of body measurements, physical and clinical examination on preliminary examination
(9) Those who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Those who has been determined to be inappropriate of the study by the investigator
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Taguchi
Organization Medical Corporation Ikuseikai, Yamaguchi hospital
Division name Internal medicine
Zip code
Address 1-19-17 Nishisugamo, Toshima-ku, Tokyo
TEL 03-6663-8890
Email info@synaps.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Yamamichi
Organization TTC Co., Ltd
Division name Clinical Research Planning Department
Zip code
Address 1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization non-disclosure
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 27 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
2015 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 19 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
2015 Year 10 Month 16 Day
Last modified on
2016 Year 02 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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