Unique ID issued by UMIN | UMIN000013575 |
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Receipt number | 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 09:50:10 |
A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.
Comparison between Ibuprofen and Loxoprofen pharmacokinetics in tear and plasma.
A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.
Comparison between Ibuprofen and Loxoprofen pharmacokinetics in tear and plasma.
Japan |
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.
Ophthalmology |
Others
NO
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.
Pharmacokinetics
Exploratory
Explanatory
Not applicable
The pharmacokinetic parameters of Ibuprofen and Loxoprofen in tear and plasma(AUC(0 to 4),AUC,Cmax,t1/2,tmax)
Safety assessment (vital sign, adverse event)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Ibuprofen single oral administration
Loxoprofen Sodium single oral administration
20 | years-old | <= |
45 | years-old | >= |
Male and Female
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.
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.
6
1st name | |
Middle name | |
Last name | Makiko Hirosawa MD |
Showa University School of Medicine
Department of Pharmacology (Clinical Pharmacology)
6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
03-3300-5247
mhiro@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Makiko Hirosawa MD |
Showa University School of Medicine
Department of Pharmacology (Clinical Pharmacology)
6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577
03-3300-5247
mhiro@med.showa-u.ac.jp
Showa University School of Medicine Department of Pharmacology (Clinical Pharmacology)
none
Self funding
NO
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)
2014 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 01 | Day |
2014 | Year | 06 | Month | 17 | Day |
2014 | Year | 07 | Month | 04 | Day |
2014 | Year | 07 | Month | 04 | Day |
2014 | Year | 08 | Month | 31 | Day |
2014 | Year | 09 | Month | 30 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 09 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015864
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