Healthy
Conditions
Keywords
Grapefruit Juice, Edoxaban
Brief summary
The aim of the study is to evaluate the effect of grapefruit juice on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults
Detailed description
Pharmacokinetics and pharmacodynamics of edoxaban without coadministration of grapefruit juice will be compared with those after administration of grapefruit juice.
Interventions
Single administration of edoxaban
OTHEREdoxaban 60 MG [Lixiana] + Grapefruit Juice
Coadministration of edoxaban and grapefruit juice
Sponsors
Hyewon Chung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 19 to 50 years of age (inclusive) at the time of screening * Subjects with BMI of 18 to 32 kg/m2 (inclusive) * Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte * Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
Exclusion criteria
* Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease * Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product * 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 * Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at Screening * 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 * Subjects whose coagulation test (aPTT, PT) exceeds the normal range at screening * 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) * 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 * Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day * Subjects who consistently consumed alcohol (alcohol 21 units/week \[1 unit = 10 g of pure alcohol\]) within 2 weeks of the first administration day * Subjects who consumed grapefruit or grapefruit juice within 2 weeks of the first administration day * Pregnant or breastfeeding women * 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 | Description |
|---|---|---|
| Cmax | 24 hours post-dose | maximum concentration |
| AUCinf | 24 hours post-dose | Area under the concentration-time curve from time of administration extrapolated to infinity |
| PT | 24 hours post-dose | prothrombin time |
| aPTT | 24 hours post-dose | activated partial thromboplastin time |
| TGA | 24 hours post-dose | Thrombin generation assay |
Countries
South Korea
Outcome results
None listed