UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019387 |
|---|---|
| Receipt number | 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 17:02:59 |
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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
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
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022422
