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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025366
Receipt No. 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 2017/12/23

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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
Middle name
Last name Naoki Uchida
Organization Showa University
Division name Department of Pharmacology, School of Medicine
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku, Tokyo 1578577, Japan
TEL 03-3300-5254
Email nuchida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name ken-ichi Fujita
Organization Showa University
Division name Institute of Molecular Oncology
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 1428555, Japan
TEL 03-3784-8146
Homepage URL
Email k.fujita@med.showa-u.ac.jp

Sponsor
Institute Department of Pharmacology, School of Medicine, Showa University
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2017 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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