UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025366 |
|---|---|
| Receipt number | R000029202 |
| Scientific Title | Effects of free fatty acids on the serum protein binding of flurbiprofen |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2020/06/25 10:44:10 |
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Basic information
Public title
Effects of free fatty acids on the serum protein binding of flurbiprofen
Acronym
Protein binding of flurbiprofen and fatty acids
Scientific Title
Effects of free fatty acids on the serum protein binding of flurbiprofen
Scientific Title:Acronym
Protein binding of flurbiprofen and fatty acids
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Free fatty acid concentration is higher in a fasted condition, whereas lower in a condition with elevated glucose level. We examine the effects of higher free fatty acid concentration after 10 hours of fasting on the free serum concentration of flurubiprofen.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Healthy adults are received intravenous injection of flurubiprofen twice (1) after the fasting more than 10 hours in the night, and (2) one hour after taking the 75 g of glucose after the fasting more than 10 hours in the night. In both groups, serum concentrations of free and total (free and serum protein bound) flurubiprofen and fatty acids were measured and compared. The study is performed with one group 2 periods cross over design (fixed sequential design).
Primary endpoint is the difference in serum free flurubiprofen concentrations in alpha-phase between 2 treatments.
Key secondary outcomes
Secondary endpoint is to examine the properties of serum protein binding in each subject.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug 1:Flurubiprofen axetil 50 mg
Drug 2:Glucose 75g (TRELAN-G75)
Day1 After the 10 hours fasting in the night, drug 1 is given.
Day2 After the 10 hours fasting in the night, drug 2 is given. After one hours, drug1 is given.
Interventions/Control_2
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy adults with age at obtaining informed consent of equal to or older than 20 years and youngerthan45 years.
2)Healthy adults who give informed consent regarding the participation to this strudy.
Key exclusion criteria
1)Healthy adults with contraindication to drugs used in this study.
2)Healthy adults who are disqualified by physician(s).
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Uchida |
Organization
Showa University
Division name
Department of Pharmacology, School of Medicine
Zip code
157-8577
Address
6-11-11 Kitakarasuyama Setagaya-ku, Tokyo 1578577, Japan
TEL
03-3300-5254
nuchida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | ken-ichi |
| Middle name | |
| Last name | Fujita |
Organization
Showa University
Division name
Institute of Molecular Oncology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 1428555, Japan
TEL
03-3784-8146
Homepage URL
k.fujita@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Pharmacology, School of Medicine, Showa University
Institute
Department
Personal name
Funding Source
Organization
Institute of Molecular Oncology, Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 1428555, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.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
| 2017 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
6
Results
The effects of the intake of glucose on the protein binding.
Results date posted
| 2020 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy
Participant flow
As planed
Adverse events
No
Outcome measures
plasma protein binding
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029202
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
