UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036938 |
|---|---|
| Receipt number | R000042085 |
| Scientific Title | Pharmacokinetic comparative study of plant-derived components in healthy male volunteers |
| Date of disclosure of the study information | 2019/06/03 |
| Last modified on | 2019/07/30 17:21:44 |
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Basic information
Public title
Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Acronym
Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Scientific Title
Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Scientific Title:Acronym
Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Region
| Japan |
Condition
Condition
Healthy male adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing oral absorbency among test foods.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUCt and Cmax calculated from plasma component concentrations at ingestion of test 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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food, Washout(14 days or more), Single ingestion of test food of 2 capsule, Washout(14 days or more), Single ingestion of test food of 4 capsule
Interventions/Control_2
Single ingestion of test food, Washout(14 days or more), Single ingestion of test food of 4 capsule, Washout(14 days or more), Single ingestion of test food of 2 capsule
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese healthy male volunteers with 20 to 40 years of age when written informed consent is obtained
2) Subjects with BMI of 18.5 and above to below 25.0 at screening test
3) Subjects who are judged as eligible in the screening test by the principal (or sub) doctor
4) Subjects who realize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1) Subjects who have a disease under treatment
2) Subjects who are sensitive to drugs or food , or have idiosyncrasy or the history of idiosyncrasy
3) Subjects with allergy disease such as bronchial asthma, pollenosis, atopic dermatitis etc
4) Subjects who have diseases of heart, liver, kidney, digestive organs, respiratory organs and blood function or the history of the diseases or the severe operation history of the diseases and are judged as ineligible to participate in the study by the principal (or sub) doctor (excluding extirpation of appendicitis)
5) Subjects with positive reaction in immunological serum testing at screening test
6) Subjects who take foods for specified health uses , foods with function claims and foods with nutrient function claims (supplements in capsule form and others), excluding those who can stop taking those foods after informed consent)
7) Subjects who cannot keep no smoking in hospital and temperance from 2 days before
8) Subjects who used drugs or took drugs within one week before ingestion of test food or need to use drugs or take drugs in the first period
9) Subjects who participated in other clinical trials and received medication within 12 weeks before ingestion of test food in the first period
10) Subjects who donated 400 mL or 200 mL of blood within 12 or 4 weeks before ingestion of test food or have the schedule of donation of blood component (plasma or platelet) or donated the component within 2 weeks before ingestion of test food in the first period
11) Subjects who are judged as ineligible to participate in the study for other reasons by the principal (or sub) doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ishikawa |
Organization
Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name
internal medicine
Zip code
004-0004
Address
2-1-30, Atsubetsuhigashi 4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL
011-898-2151
chiken-be@hpgr.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Tomita |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1Toiso, Eniwa-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Alps Pharmaceutical Inc. Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Alps Pharmaceutical Inc. 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
Miyawaki Orthopedic Clinic Industrial Review Board
Address
3-1-6 Ariaketyou,Eniwa-shi,Hokkaido, Japan
Tel
0123-33-4026
d-kameda@mediffom.co.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
| 2019 | Year | 06 | Month | 03 | 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
10
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
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042085
