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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013575
Receipt No. R000015864
Scientific Title A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.
Date of disclosure of the study information 2014/06/01
Last modified on 2014/09/30

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Basic information
Public title A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.
Acronym Comparison between Ibuprofen and Loxoprofen pharmacokinetics in tear and plasma.
Scientific Title A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.
Scientific Title:Acronym Comparison between Ibuprofen and Loxoprofen pharmacokinetics in tear and plasma.
Region
Japan

Condition
Condition In order to investigate the ocular damage caused by of typical NSAIDs, single dose of 200mg of Ibuprofen and 60mg of Loxoprofen Sodium will be orally administered to Japanese healthy subjects, with cross over design. Wash out is set as one week. Pharmacokinetics parameters in tear fluid and plasma after oral administration of these drugs will be measured. The differences in PK parameters between the drug and also between tear and plasma will be analyzed. In addition to these, safety assessment will be compared between the drugs.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to investigate the ocular damage caused by of typical NSAIDs, single dose of 200mg of Ibuprofen and 60mg of Loxoprofen Sodium will be orally administered to Japanese healthy subjects, with cross over design. Wash out is set as one week. Pharmacokinetics parameters in tear fluid and plasma after oral administration of these drugs will be measured. The differences in PK parameters between the drug and also between tear and plasma will be analyzed. In addition to these, safety assessment will be compared between the drugs.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The pharmacokinetic parameters of Ibuprofen and Loxoprofen in tear and plasma(AUC(0 to 4),AUC,Cmax,t1/2,tmax)
Key secondary outcomes Safety assessment (vital sign, adverse event)

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Ibuprofen single oral administration
Interventions/Control_2 Loxoprofen Sodium single oral administration
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) Age: 20 - 45 years old at the time of informed consent
2) Subjects are competent to consent, keep the rules of the study and are able to report self condition.
3) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Key exclusion criteria 1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, asthma, and the disease of digestive organ, heart, liver, kidney, lungs, eye, blood etc.) and who is taking any drugs (including health supplements).
2) Subjects who is taking any drugs (including health supplements).
3) Pregnant women, Lactional women.
4) Any history for drug allergy.
5) 10 mm or less in the Schirmer test paper method.
6) Subjects within three months after the participation to other clinical trials.
7) Subjects who are inadequate for enrollment judged by the investigator.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makiko Hirosawa MD
Organization Showa University School of Medicine
Division name Department of Pharmacology (Clinical Pharmacology)
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL 03-3300-5247
Email mhiro@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Hirosawa MD
Organization Showa University School of Medicine
Division name Department of Pharmacology (Clinical Pharmacology)
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
TEL 03-3300-5247
Homepage URL
Email mhiro@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine Department of Pharmacology (Clinical Pharmacology)
Institute
Department

Funding Source
Organization none
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 昭和大学臨床薬理研究所(東京都)
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 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 Completed
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 17 Day
Last follow-up date
2014 Year 07 Month 04 Day
Date of closure to data entry
2014 Year 07 Month 04 Day
Date trial data considered complete
2014 Year 08 Month 31 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 31 Day
Last modified on
2014 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015864

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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