A clinical trial to evaluate the effect of Banhabaekchulcheonmatang and Hwangryeonhaedoktang on the pharmacokinetics and pharmacodynamics of edoxaban in healthy adults
- Conditions
- Not Applicable
- Registration Number
- KCT0008412
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
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
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 Banhabaekchulcheonmatang or Hwangryeonhaedoktang
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUClast, AUCinf, Tmax, t1/2 of edoxaban and M4
- Secondary Outcome Measures
Name Time Method 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