UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056705 |
|---|---|
| Receipt number | R000064786 |
| Scientific Title | Comparative study of human absorption of Q10 formulation -2 (fasting condition) |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/10 11:09:00 |
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Basic information
Public title
Comparative study of human absorption of Q10 formulation -2 (fasting condition)
Acronym
Comparative study of human absorption of Q10 formulation -2 (fasting condition)
Scientific Title
Comparative study of human absorption of Q10 formulation -2 (fasting condition)
Scientific Title:Acronym
Comparative study of human absorption of Q10 formulation -2 (fasting condition)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the absorbability of two Q10 formulations in humans in fasting condition.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of total CoQ10 concentration in plasma
Key secondary outcomes
Evaluation of reduced CoQ10 concentration, oxidized CoQ10 concentration, and reduced/total CoQ10 ratio in plasma
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 intake of test food A , Washout , Single intake of test food B
Interventions/Control_2
Single intake of test food B , Washout , Single intake of test food A
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) Healthy males aged of 20-39 years.
2) Subjects whose BMI18.5 kg/m2 <= and <25.0 kg/m2.
3) Subjects who can visit the clinic on the scheduled visit date
4) Subjects who agreed in writing with sufficient understanding of the purpose and contents of this study
Key exclusion criteria
1) Subjects who have systolic blood pressure <90 mmHg
2) Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks
3) Subjects who donated their whole blood 400mL within the past 12 weeks
4) Subjects being collected in total of their blood 1,200mL within the past 12 months and in this research
5) Subjects who participated in other clinical studies in the past 4 weeks or who are scheduled to participate in another study during the study period
6) Subjects who meet any of the following:
a) suffering from heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to the test food
e) Subjects with a positive or suspected positive test for infectious diseases
7) Subjects who are under treatment at the time of obtaining consent to participate in the study
8) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection
9) Subjects who have some kind of food allergy
10) Subjects who have experienced sickness due to blood collection
11) Subjects who have difficulty drawing blood from the peripheral vein
12) Heavy drinker (over 40g alcohol/day)
13) Subjects who quit smoking for less than 6 months or smokers
14) Subjects whose eating habits are extremely irregular
15) Subjects who are shift workers and night workers
16) Subjects who have used medicines within 1 week of ingestion of the test food
17) Subjects who use oral medication or supplements which may affect this study or ingested within 1 month
18) Subjects judged as unsuitable for this study by the principal investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Morikawa |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition SV Supplement Strategic Unit
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-7673
Hideyuki.Morikawa@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Murase |
Organization
TRANSGENIC INC.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
kanako.murase@transgenic.co.jp
Sponsor or person
Institute
KANEKA CORPORATION
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
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 Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
| 2025 | Year | 01 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064786
