None Healthy adult
Conditions
Interventions
1) Store temocapril 2mg and magnesium oxide 330mg in tablet form for more than 28 days under under the accelerated testing conditions. Take the above two drugs as tablets.
2) Store temocapril 2mg and
Sponsors
Sambe Takehiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age : Those who are older than age 20 and under 35 when obtaining consent. 2) Gender : male 3) Those who have the ability to consent and can observe the pre-examinations prescribed in this research implementation plan and report subjective symptoms etc. 4) Those that are judged to be helthy and eligible for participation in this study group by doctors in charge of research in the pre-examinations stipulated in this research implementation plan.
Exclusion criteria
Exclusion criteria: 1)Persons with a history that may affect the evaluation and safety of this study. For example, drug abuse-dependent, alcohol abuse-dependent and heart, liver, kidney, eye and vascular disease etc. 2)Those taking medications ( includes supplements and health supplements ) that may affect the evaluation and safety of this study. 3)Those with a history of drug allergies. 4)Within 3 months of participation in other clinical trials. 5)Others, What the research doctor determined to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters ( AUC0->24 , Cmax ) of temocaprilart ( Active body ) in serum, analyzing the values of each period using the Wilcoxon signed rank test with the measured value of 1st period as the control. Then the significance level is 0.05. In addition, evaluate the 95% confidence interval to see if there are differences in the 1 - 3 period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters ( t1/2 , tmax) of temocaprilart ( active body ) in serum, analyzing the values of each period using the Wilcoxon signed rank test with the measured value of 1st period as the control. Then the significance level is 0.05. In addition, evaluate the 95% confidence interval to see if there are differences in the 1 - 3 period. | — |
Contacts
Public ContactTakehiko Sambe
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Outcome results
None listed