UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044073 |
|---|---|
| Receipt number | R000050316 |
| Scientific Title | Pharmacokinetics study o of a food containing botanical extract - Randomized crossover study - |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/10/31 18:52:31 |
* 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
Pharmacokinetics study of a food containing botanical extract
- Randomized crossover study -
Acronym
Pharmacokinetics study of a food containing botanical extract
Scientific Title
Pharmacokinetics study o of a food containing botanical extract
- Randomized crossover study -
Scientific Title:Acronym
Pharmacokinetics study of a food containing botanical extract
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of functional food
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum observed plasma concentration, Maximum time plasma concentration, Area under the plasma concentration-time curve from time zero to the time of the last measurable drug concentration
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food 1 -> Washout(1day) -> Single ingestion of test food 2
Interventions/Control_2
Single ingestion of test food 2 -> Washout(1day) -> Single ingestion of test food 1
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Males equal to or more than 20 years and less than 39 years of age
2)Subjects who BMI18.5=> kg/m2 and <30kg/m2
3)Subjects who visit on schedule days
4)Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1)Subjects who have systolic blood pressure <90 mmHg
2)Subjects who donated 200 mL or more of blood within 4 weeks from the start of the study
3)Subjects who donated 400 mL or more of blood within 12 weeeks from the start of the study
4)Subjects who donated 1200 mL over or more of blood within 12 months from the start of the study
5)Subjects who participated in other clinical studies in the past 4 weeks
6)Subjects who fall under any of the following items
a) Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
b) Subjects who are under treatment or have a history of cardiovascular disease
c) Subjects who develop diabetes
d) Subjects who have allergy related to the study foods
7)Subjects who are under treatment
8)Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection
9)Subjects who have allergy related to the foods
10)Subjects who have experienced sickness due to blood collection
11)Subjects who have difficulty drawing blood from the peripheral vein
12)Heavy alcoholic beverager(40g alcohol/day>=)
13)Subjects who quit smoking for less than 6 months or smokers
14)Subjects whose eating habits are extremely irregular
15)Shift worker and night worker
16)Subjects who took medicine before the study
17)Subjects who use oral supplements which may affect this study
18)Subjects who the physician's judgement found difficult to consume the test foods
19)Subjects who are ineligible due to physician's judgement
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hoshino |
Organization
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name
General Medicine Clinical Departments : Internal Medicine Respiratory Medicine Allergy
Zip code
003-0011
Address
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-868-2711
n-abe@medi-ate.jp
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
t-ashino@ndrcenter.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
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
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2 jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
s-fukui@jikokai.jp
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
| 2022 | Year | 01 | Month | 01 | 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
16
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
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050316
