A phase 1 study to evaluate the effect of food on the pharmacokinetics of BS-112 and to compare the pharmacokinetics and safety of BS-112 to BY-XRT in healthy subjects
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006383
- Lead Sponsor
- Bio-Synectics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1) Healthy subject, 19 years= Age = 65 years at the time of screening
2) 18.0 kg/m² = BMI = 30.0 kg/m² (BMI = Body weight(kg)/{Height(m)}²)
- Male body weight = 50 kg
- Female body weight = 45 kg
3) Subject who has no congenital or chronic diseases and no abnormal symptoms or signs based on medical examinations (if needed, EEG, ECG, thoracoscopy and gastroscopy, or gastrointestinal radiology examination)
4) Subject who is deemed to be appropriate as the study subject in accordance with the laboratory results(hematology test, blood chemistry test, blood clotting test, serology test, urinalysis, etc.) and ECG results
5) Subject who has decided to participate in the clinical trial with willingness after fully understanding the clinical trial after in-depth explanation and signs a written informed consent form to follow the subject's precautions during the clinical trial
6) Subject who agrees to use a clinically acceptable method of contraception during the clinical trial(from the first dose to 1 week after the last dose)
1) Subject who has a clinically significant digestive, cardiovascular, endocrine, respiratory, haemato-oncology, infectious, renal and genitourinary, neuropsychologic, musculoskeletal, immunologic, otolaryngologic, skin, or eye diseases or who has a medical history of the diseases
2) Subject who has taken drugs which would induce or inhibit drug-metabolizing enzymes like barbiturates within 1 month before the first dosing. Subject who has taken the drug that would affect the study within 10 days before the first dose of study drug
3) Subject who has participated in a clinical trial and has received an investigational product within 6 months before the first dosing day in the current study
4) Subject who has donated whole blood or component blood within 8 weeks or 2 weeks respectively before the first dose of study treatment or who has received a blood transfusion within 4 weeks before the first dose.
5) Subject who has or has a medical history of gastrointestinal diseases (excluding simple appendectomy or hernia surgery) that could interfere with absorption of the investigational product
6) Subject who drinks (Man > 21 glasses/week, Female >14 glasses/week) or smokes (> 20 cigarettes/day) to excess within 1 month prior to first dosing day.
7) Subject who cannot abstain from consuming grapefruit-containing food from 3 days before the first dose to the end of the clinical trial
8) Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9)
- Subject who is hypersensitive to rivaroxaban or any of the excipients in investigational products or who has clinically significant bleeding (e.g. intracranial bleeding, gastrointestinal bleeding) or who with significant hepatic disease (including moderate to severe hepatic impairment, i.e. Child-Pugh B and C) especially when it is associated with coagulopathy leading to a clinically relevant bleeding risk
- Subject who has an increased risk of bleeding due to the following diseases
(1) recent gastrointestinal ulcers
(2) recent intracranial or intracerebral bleeding
(3) intraspinal or intracerebral vascular abnormalities
(4) recent brain, spinal cord, or ophthalmic surgery
(5) recent brain or spinal cord injury
(6) suspected or confirmed esophageal varices
(7) arteriovenous malformations
(8) vascular aneurysms
(9) malignant neoplasms at high risk of bleeding
- Subject who receives concomitant treatment with any other anticoagulants, e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.)
- Subject who has a medical history of stroke or transient ischemic attack and receives concomitant treatment with antiplatelet drugs in treatment of acute coronary syndrome
10) Subject who is deemed to be inappropriate to participate in the study by the investigator due to reasons other than the above inclusion/exclusion criteria
11) Subject who is lactating or suspected of pregnancy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt and Cmax
- Secondary Outcome Measures
Name Time Method AUC8, AUCt/AUC8, Tmax, and t1/2