None listed
Conditions
Interventions
Drug : Edoxaban administered alone: Single oral administration of edoxaban 60 mg
Edoxaban coadministered with Bojungikgitang: Oral administration of Bojungikgitang three times daily for nine days, Sin
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to 50 years of age (inclusive) at the time of screening 2) Subjects with BMI of 18 to 32 kg/m2 (inclusive) 3) Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte 4) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
Exclusion criteria
Exclusion criteria: 1) Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease 2) Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product 3) Subjects who have clinically significant hemorrhage or increased risk of hemorrhage due to the following conditions A. Recent history of gastrointesinal ulcers B. Malignant tumor with a high risk of bleeding C. Recent brain or spinal cord injury D. Recent brain, spinal cord, or opthalmic surgery E. Recent history of intracranial or intracerebral hemorrhage F. Esophageal varices, arterial malformations, vascular aneurysms, or spinal cord or cerebral vascular abnormalities G. Coagulation disorders, thrombocytopenia, or platelet dysfunction H. Recent biopsy or major trauma I. Bacterial endocarditis J. Esophagitis, Gastritis, or Gastroesophageal reflux 4) Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 5) Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at screening 6) Subjects whose AST or ALT levels are more than 2 times the upper limit of normal range, or total bilirubin levels are more than 1.5 times the upper limit of normal range at screening 7) Subjects whose coagulation test (aPTT, PT) exceeds the normal range at screening 8) Subjects who have taken the following medication or medication known to have significant drug interactions with the investigational product within the 2 weeks prior to the first administration day A. Strong P-gp inhibitor or inducer B. Acetylsalicylic acid, antiplatelet agent, anticoagulant, fibrinolytic agent, non-steroidal anti-inflammatory drug (NSAID), selective serotonin reuptake inhibitor (SSRI), or selective serotonin-norepinephrine reuptake inhibitor (SNRI) C. Herbal medicine, Korean traditional medicine, or supplements that contains the ingredients of Bojungikgitang, Ijintang, or Cheongsanggyeontongtang 9) Subjects who donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration day 10) Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day 11) Subjects who consistently consumed alcohol (alcohol > 21 units/week [1 unit = 10 mL of pure alcohol]) within 2 weeks of the first administration day 12) Pregnant or breastfeeding women 13) Subjects judged unsuitable to participate in the clinical study by investigators due to other reasons, including the results of laboratory tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Edoxaban M4 Cmax, AUClast, AUCinf, Tmax, t1/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the effect curve (AUEC), maximum observed response (Rmax), change from baseline in Rmax value (?Rmax), and percent change from baseline in Rmax value (%?Rmax)) of PT and aPTT | — |
Countries
Korea, Republic of
Contacts
Public ContactHyewon Chung
Koera University Guro Hospital
Outcome results
None listed