A study to compare between Ibuprofen and Loxoprofen Sodium in tear and plasma pharmacokinetics after oral administration in Japanese healthy subjects.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013575

Enrollment

Registered

2014-06-01

Start date

2014-06-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 w

Interventions

Ibuprofen single oral administration Loxoprofen Sodium single oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic parameters of Ibuprofen and Loxoprofen in tear and plasma(AUC(0 to 4),AUC,Cmax,t1/2,tmax)	—

Secondary

Measure	Time frame
Safety assessment (vital sign, adverse event)	—

Countries

Japan

Contacts

Public ContactMakiko Hirosawa MD

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

mhiro@med.showa-u.ac.jp03-3300-5247

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026