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UMIN-CTR Clinical Trial |
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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 |
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. | |
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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 |
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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 |
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Interventions/Control_1 | Ibuprofen single oral administration | |
Interventions/Control_2 | Loxoprofen Sodium single oral administration | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_7 | ||
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Eligibility | ||||
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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. |
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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. |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mhiro@med.showa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
mhiro@med.showa-u.ac.jp |
Sponsor | |
Institute | Showa University School of Medicine Department of Pharmacology (Clinical Pharmacology) |
Institute | |
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Funding Source | |
Organization | none |
Organization | |
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Category of Funding Organization | Self funding |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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