Bioequivalence Study,
Conditions
Interventions
Rivaroxaban 20 mg Tablets from India. Each tablet contains Rivaroxaban 20 mg, Xarelto® 20 mg Each tablet contains Rivaroxaban 20 mg
Active Comparator Drug,Active Comparator Drug
Rivaroxaban 20 mg Tablets,Bayer Xarelto®,
Sponsors
International Bio Service Co.,Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1. 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-smoker and non-consumer of nicotine containing products Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked or stopped for at least 90 days. 5.Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 6.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 nonhormonal 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 7.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. 8.Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study. 9.Adequate venous access in both arms for the collection of a number of samples during the study
Exclusion criteria
Exclusion criteria: 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. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular, psychiatric (e.g. depression), neurologic (e.g. convulsant), 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 or evidence of coagulation disorders e.g. von Willebrand's disease, hemophilia 5.Active clinically significant bleeding e.g. intracranial or intracerebral bleeding, gastrointestinal bleeding 6.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. 7.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 8.History of sensitivity to heparin or heparin-induced thrombocytopenia 9.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 10.History of preceding diarrhea within 24 hours prior to check-in in each period 11.History of febrile illness within 7 days prior to check-in in each period 12.History of problems with swallowing tablet or capsule 13.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 14.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 subject‟s eligibility. 15.12-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 subject‟s eligibility. 16.Investigation with blood sample shows positive test for HBsAg. 17.Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 18.Have renal creatinine clearance (Clcr) <50 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-G
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rivaroxaban plasma concentration 0-48 hrs Cmax, AUC0-tlast and AUC0-∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Rivaroxaban plasma concentration 0-48 hrs Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT ,Rivaroxaban plasma concentration 0-48 hrs Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT | — |
Countries
Thailand
Contacts
Public ContactPorranee puranajoti
International Bio Service Co., Ltd.
Outcome results
None listed