UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023079 |
|---|---|
| Receipt number | R000026601 |
| Scientific Title | Bioequivalence study of commercial imidazole dipeptides in healthy adults. |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2017/07/12 09:55:28 |
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Basic information
Public title
Bioequivalence study of commercial imidazole dipeptides in healthy adults.
Acronym
Bioequivalence study of commercial imidazole dipeptides in healthy adults.
Scientific Title
Bioequivalence study of commercial imidazole dipeptides in healthy adults.
Scientific Title:Acronym
Bioequivalence study of commercial imidazole dipeptides in healthy adults.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the bioequivalence of commercial imidazole dipeptides
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cmax
AUCt
Key secondary outcomes
Cmax
AUCt
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are 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
Commercial imidazole dipeptide A, washout, Commercial imidazole dipeptide B
Interventions/Control_2
Commercial imidazole dipeptide B, washout, Commercial imidazole dipeptide 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 to less than 60 years old.
2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who have systolic blood pressure over 150 mmHg.
2) Subjects who have total serum cholesterol over 260 mg/dL.
3) Subjects who have ALT, AST and ganma-GTP more than twice the standard value.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenobu Shiotani |
Organization
Tokaibussan Co., Ltd
Division name
research division
Zip code
Address
2391 Kunimoto, Fukuroi City, Shizuoka, JAPAN 437-0012
TEL
0538-42-1410
shiotani@tokaibsn.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Sato |
Organization
Tokaibussan Co., Ltd
Division name
Sales department
Zip code
Address
1-10-5 Iwamotocho, Tokyo, JAPAN 101-0032
TEL
03-3864-6861
Homepage URL
sato@tokaibsn.co.jp
Sponsor or person
Institute
Tokaibussan Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Tokaibussan Co., Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
小川町メディカルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were no differences in the bioavailability and plasma levels of the related compounds of the two commercial imidazole dipeptides.
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
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2017 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026601
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
