UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019623 |
|---|---|
| Receipt number | R000022679 |
| Scientific Title | A pharmacokinetic study of botanical ingredient-containing foods. |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2016/03/25 16:07:59 |
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Basic information
Public title
A pharmacokinetic study of botanical ingredient-containing foods.
Acronym
A pharmacokinetic study of botanical ingredient-containing foods.
Scientific Title
A pharmacokinetic study of botanical ingredient-containing foods.
Scientific Title:Acronym
A pharmacokinetic study of botanical ingredient-containing foods.
Region
| Japan |
Condition
Condition
Life style related disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pharmacokinetic study of botanical ingredient-containing foods.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum food ingredient level Pharmacokinetic parameter after single intake a botanical ingredient-containing food
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Botanical ingredient-containing foods 1, single administration.
washout.
Botanical ingredient-containing foods 2, single administration.
Interventions/Control_2
Botanical ingredient-containing foods 2, single administration.
washout.
Botanical ingredient-containing foods 1, single administration.
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
| Not applicable |
Gender
Male
Key inclusion criteria
20 years of age or older.
Body weight is over 50 kg.
Body mass index is between 18.5 and less than 25 kg/m2.
Submitting the written informed consent before this study.
Key exclusion criteria
With treatment.
Use of medicine before 1 week the test food intake.
Whether syphilis,HBs antigen and an HCV antibody an HIV antigen and an antibody and HTLV-I antibody test result at the time of a screening.
Investigator's judgment for other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Zeida |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0460
Mitsuhiro_zeida@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Yoshimura |
Organization
Suntory Business Expert Limited
Division name
HE center
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0535
Homepage URL
Makiko_Yoshimura@suntory.co.jp
Sponsor or person
Institute
Clinical Support Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
医療法人北武会 美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 05 | 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 | 11 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022679
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
