Healthy Adults
Conditions
Interventions
The study will be conducted using a randomized, open-label, three-drug, three-phase crossover method with a single postprandial administration of the developed drug (Edoxaban OD Tablets 60 mg) and the
Z1903-23
Sponsors
Hida Noriko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese healthy adult male applicants who are between 18 and 40 years of age at the time of consent 2) BMI between 18.5 and 25.0 at the time of screening 3) Have an estimated creatinine clearance of 81 mL/min or greater as calculated by the Cockcroft-Gault formula at the time of the screening test. 4) Subjects who are judged by the principal investigator or subinvestigator to be eligible for participation in the study, taking into consideration the applicant's background, physical examination, physiological examination, and laboratory test results obtained as a result of the screening test. 5) Subjects who are capable of complying with the compliance requirements during participation in the research as stipulated in the research protocol.
Exclusion criteria
Exclusion criteria: 1) Individuals who are currently undergoing treatment for a disease. 2) Individuals with diseases of the gastrointestinal tract, heart, liver, kidney, blood, etc. that may affect pharmacokinetics, or whose history of such diseases is deemed by the principal investigator or subinvestigator to interfere with their participation in the study. 3) Individuals with a history of major gastrointestinal surgery, including gastrectomy, gastrointestinal suture, or intestinal resection. 4) Individuals with a body weight of less than 40 kg. 5) Those who are hemorrhaging 6) Those who bruise or bleed easily. 7) Individuals who have undergone a procedure involving bleeding, such as surgery or tooth extraction, within one week prior to the administration of the Phase 1 study drug. 8) Individuals with a history of hemorrhagic stroke or a history of surgery in the brain, spinal cord, or ophthalmologic field. 9) Individuals with a wound. 10) Individuals with hemorrhoids. 11) Individuals with a platelet count below 100,000/mm3 at the time of screening test. 12) Individuals with hepatic disorder. Biliary obstruction, renal disorder, or a history of such disorders 13) Individuals with hypersensitivity, allergy, or idiosyncrasy to the ingredients of this drug or other drugs, or those with a history of such hypersensitivity, allergy, or idiosyncrasy. 14) Individuals with a history of allergic diseases, such as hay fever and atopic dermatitis. 15) Individuals with a history of alcohol or substance dependence 16) Individuals with positive results in any of the immunological tests 17) Individuals who are unable to abstain from smoking during the period of admission until the time of discharge. 18) Individuals who have consumed or will consume alcohol, grapefruit/citrus fruits, St. John's wort-containing foods or beverages, or health foods within one week prior to the administration of the Phase I study drug. 19) Individuals who have engaged in or will engage in excessive exercise or labor involving muscular fatigue within one week prior to the administration of the Phase I study drug. 20) Individuals who have participated in a clinical trial of a drug containing a new active ingredient within 16 weeks, another clinical trial within 12 weeks, or a patch test within four weeks prior to administration of the Phase I study drug and have received the drug. 21) Individuals who have used other drugs within one week prior to administration of the Phase 1 study drug and who will be required to use other drugs by the end of the study. 22) Individuals who have undergone a whole blood collection of 400 mL or more within 12 weeks prior to administration of the Phase I research drug, or a whole blood collection of 200 mL or more within 4 weeks, or a component blood collection within 2 weeks. 23) Any other person deemed ineligible as a subject for this study by the principal investigator or a subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration - time curve extrapolated to infinity, tmax, MRT, kel | — |
Contacts
Public ContactNoriko Hida
SHOWA Medical University
Outcome results
None listed