UMIN-CTR Clinical Trial

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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