None listed
Conditions
Interventions
Drug : The study drug is Hanmi Riroxban Tablet (rivaroxaban), administered as a single oral dose with 150 mL of room-temperature water within 30 minutes after a meal on the morning of Day 1 in all gro
the groups differ in renal function status and administered dose. Pharmacokinetic blood sampling is performed pre-dose (0 hours) and at 1, 2, 4, 6, 9, 12, and 24 hours post-dose.
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria must be met for participation in this study. Age: Men and women aged 65 years or older at screening Body size: Body weight of 55 kg or more for men and 50 kg or more for women, with a body mass index (BMI) between 18.0 and 30.0 kg/m² Renal function: Creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation within the following ranges — elderly with normal renal function or mild renal impairment: CLcr = 50 mL/min; elderly with moderate renal impairment: 30 mL/min = CLcr < 50 mL/min Cognitive function: Subjects judged to have intact cognitive function with the capacity to understand the study and provide consent Written informed consent: Subjects who voluntarily decided to participate and signed the written informed consent form after receiving a detailed explanation of the study Communication: Subjects able to understand and comply with study procedures and requirements, and able to communicate adequately throughout the study period
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are excluded from this study. Clinically significant active bleeding (gastrointestinal bleeding, hemoptysis, hematuria, intracranial hemorrhage, etc.) Diseases or conditions that increase the risk of bleeding (congenital or acquired bleeding tendency such as hemophilia or von Willebrand disease, thrombocytopenia (platelet count 100 mg/day, clopidogrel, ticagrelor, etc.), or nonsteroidal anti-inflammatory drugs within 2 weeks before screening (acetaminophen is permitted if needed) History of hypersensitivity to rivaroxaban or any component of the study drug, including excipients Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption History of malignancy within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ) Clinically significant cardiovascular disease such as uncontrolled heart failure, myocardial infarction within the past 3 months, or unstable angina Neuropsychiatric disorders such as Alzheimer's disease, Parkinson's disease, severe depression, or schizophrenia that would make study participation difficult Positive serology results (HBsAg, Anti-HCV antibody, HIV Ag/Ab, syphilis reagin test) History of drug abuse or suspected current drug abuse Excessive alcohol intake (210 g or more per week) or caffeine intake (more than 5 cups per day) that cannot be restricted during the study period Smokers of more than 10 cigarettes per day who cannot abstain during the study period Use of prescription medications or herbal medicines within 14 days before screening (permitted with the investigator's approval if used as stable chronic disease treatment without interaction with the study drug or effect on study results) Use of over-the-counter medications or vitamin preparations within 7 days bef
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters following a single oral dose of rivaroxaban — maximum plasma concentration (Cmax), area under the plasma concentration-time curve to the last measurable concentration (AUClast), and area under the plasma concentration-time curve extrapolated to infinity (AUCinf). Parameters are derived by non-compartmental analysis (NCA) and compared between dose groups and renal function groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary pharmacokinetic parameters — time to maximum concentration (Tmax), elimination half-life (t1/2), apparent total clearance (CL/F), and apparent volume of distribution (V/F);Safety and tolerability — adverse events (particularly bleeding-related events), vital signs, 12-lead electrocardiogram, and changes in laboratory test values. Changes in coagulation markers (PT/INR, aPTT) are used as pharmacodynamic markers | — |
Countries
Korea, Republic of
Contacts
Public ContactYunsung Wo
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed