Healthy Adults Healthy Adults
Conditions
Interventions
In this study, the administration of indomethacin (oral spray, etc.) to healthy adults constitutes a medical practice that is beyond the scope of normal medical care as research, and thus constitutes
indomethacin
Sponsors
Hida Noriko
Momo Kenji
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Age: 20 years old or older and less than 65 years old at the time of obtaining consent. (2) Gender: Male (3) BMI: 18 to 35 (4) Who have the capacity to consent and can abide by the compliance requirements during participation in the study. (5) Persons who have been judged by the principal investigator or subinvestigator to be eligible to participate in this study during the preliminary examination as stipulated in the protocol for this study.
Exclusion criteria
Exclusion criteria: (1) Persons with a medical history (drug abuse/dependence, alcohol abuse/dependence, heart, liver, kidney, lung, eye, or blood disease, etc.) that may affect the evaluation and safety of this study. (2) Those with obvious ulcers or trauma to the oral cavity. (3) Currently undergoing dental treatment (4) History of drug allergy or allergy to indomethacin (5) Those with a history or current history of aspirin asthma (6) Are taking any medications (including dietary supplements and dietary supplements) that may affect the evaluation and safety of this study. (7) Persons who are using or may use all medications (including OTC) containing indomethacin. (8) Current smokers who are unable to quit during the study period. (9) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol on the day before and the day of the study drug for the duration of the study). (10) Those who are within three months of participating in another clinical research study. (11) Any other person who is judged by the principal investigator or a subinvestigator to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation to the oral mucosa (presence of inflammation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary indomethacin and metabolite concentrations from 0 to 8 hours Sensory evaluation and residual status by subjects and test physicians (immediately after use and 1 hour after use) | — |
Contacts
Public ContactNoriko Hida
Clinical Research Institute for Clinical Pharmacology and Therapeutics Showa University
Outcome results
None listed