none Healthy adult
Conditions
Interventions
The study was conducted on healthy Japanese adult males (aged less than 20-45 years) and the dose study was two doses of two drugs, two phases The study will be conducted as a trial, and blood levels
Sponsors
Hida Noriko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: those who were between 20 and 45 years of age at the time of obtaining consent. 2) Gender: male 3) Have the capacity to consent and adhere to the compliance requirements during participation in the research, undergo the pre-inspection specified in this research protocol, and Those who can report subjective symptoms, etc. 4) The physician in charge of the study has determined that participation in the study is not allowed by the physician in charge of the study in the preliminary examination prescribed in the study protocol. Those judged to be eligible.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history (e.g., drug abuse/dependence, alcohol abuse/dependence, cardiac, hepatic, renal, pulmonary, eye, or blood disorders) that may affect the evaluation and safety of this study. 2) Subjects with a history of peptic ulcers or current illness 3) Subjects with a tendency to bleed 4) Subjects with aspirin asthma 5) Subjects taking medications (including supplements and dietary supplements) that may affect the evaluation and safety of this study 6) Subjects with a history of drug allergy 7) Those who regularly use excessive alcohol (those who cannot maintain abstinence from alcohol during the study period) 8) Subjects who have participated in other clinical research within 3 months of their participation in the study. 9) Any other person who is judged by the physician in charge of the study to be ineligible to be the subject of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of salicylic acid in plasma (AUC0 to 12, Cmax) AUC0 to 12 and Cmax will be calculated for the two dosage forms of aspirin dispersant and aspirin mini-tablet depending on the plasma salicylic acid concentration before and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of plasma salicylic uric acid and aspirin (AUC0 to 12, Cmax) Pharmacokinetic parameters (t1/2, tmax) of salicylic acid, salicyluic acid and aspirin in plasma AUC0 to 12 and Cmax for plasma salicylic uric acid and aspirin will be calculated by pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose for plasma salicylic acid, salicylic uric acid, and aspirin, and t1/2 and tmax for plasma salicylic acid, salicylic uric acid, and aspirin, respectively. | — |
Contacts
Public ContactNoriko Hida
Clinical Research Institute for Clinical Pharmacology and Therapeutics Showa University Karasuyama Hospital
Outcome results
None listed