Healthy Adults
Conditions
Interventions
The study will be conducted on healthy Japanese adult males (18-45 years old).
The study will measure and compare blood levels of Prazaxa Capsule in two phases: Prazaxa Capsule taken with water and
Prazaxa Capsule
Sponsors
Hida Noriko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: The applicant must be at least 18 years old and less than 45 years old at the time of obtaining consent. 2) Gender: Male 3) Who have the capacity to give consent, abide by the rules of compliance during participation in the research, and are able to undergo the pre-test specified in the research protocol, and report subjective symptoms, etc. 4) Those who have been judged eligible for participation in this study by the pysician in charge of the research or othewe relevant personnel based on a preliminary examination as stipulated in the research protocol.
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) Persons with severe renal impairment, including those undergoing dialysis. 3) Persons with current bleeding symptoms, those with a bleeding diathesis, or those with hemostatic disorders. 4) Persons with organic lesions that present a clinically significant risk of major bleeding (including a hemorrhagic stroke within the past six months). 5) Persons with an indwelling spinal or epidural catheter, or those whose catheter was removed within one hour prior to the screening visit (or prior to study entry). 6) Persons who are scheduled to undergo surgery or invasive procedures (including tooth extraction) during the study period or within one week after the end of the study. 7) Persons taking medications (including supplements and dietary supplements) that may affect the evaluation and safety of this study. 8) Persons with a history of drug allergy. 9) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol during the study period). 10)Those who are within three months of participating in another clinical research study. 11) Any other person who judges by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of Dabigatran in Primary Outcome serum (AUC0-24,Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of Dabigatran in Secondary Outcome serum (t1/2, tmax, CLtot, Vd, ke) | — |
Contacts
Public ContactIori Taki
Showa Medical University
Outcome results
None listed