Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets in Healthy Thai Volunteers
- Conditions
- Healthy volunteerRivaroxaban, Bioequivalence Study, Healthy Thai Volunteer
- Registration Number
- TCTR20220722006
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 50
1. Healthy Thai male or female subjects between the ages of 18 to 55 years 2. Body mass index between 18.0 to 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding 5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2. 7. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
1. History of allergic reaction or hypersensitivity to rivaroxaban or to any excipients of tablet 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19. 4. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period. 5. History or evidence of coagulation disorders e.g. von Willebrands disease, hemophilia 6. Active clinically significant bleeding e.g. intracranial or intracerebral bleeding, gastrointestinal bleeding 7. History or evidence of disorders with increased bleeding risk e.g. periodontosis, hemorrhoids, recent gastrointestinal bleeding or ulceration such as acute gastritis, peptic ulcer, inflammatory bowel disease, gastroesophageal reflux disease, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, oesophageal varices, oesophagitis, arteriovenous malformations, vascular aneurysms, vascular retinopathy or major intraspinal or intracerebral vascular abnormalities, bronchiectasis or history of pulmonary bleeding 8. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 9. History of sensitivity to heparin or heparin-induced thrombocytopenia 10. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 11. History of diarrhea or vomiting within 24 hours prior to check-in in each period 12. History of febrile illness within 7 days prior to check-in in each period 13. History of problems with swallowing tablet or capsule 14. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 15. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subjects eligibility. 16. 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subjects eligibility. 17. Have renal creatinine clearance (CrCl) < 50 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test or during enrollment 18. Abnormal liver function, >= 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 19. Investigation with blood sample shows positive test for HBsAg. 20. History or evidence of habitual use of tobac
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma rivaroxaban concentrations 0.00-48.00 hours post-dose Cmax, AUC0-tlast and AUC0-inf
- Secondary Outcome Measures
Name Time Method Plasma rivaroxaban concentrations 0.00-48.00 hours post-dose Tmax, t1/2, AUC0-tlast/AUC0-inf, AUC%extrapolate, Kel and MRT