Healthy volunteers Bioequivalence Rivaroxaban Pharmacokinetics Healthy volunteers
Conditions
Interventions
Rivaroxaban Film-Coated Tablets 20 mg,Rivaroxaban Film-coated Tablets 20 mg
Experimental Drug,Active Comparator Drug
Rivaroxaban Film-Coated Tablets 20 mg,Xarelto 20 mg
Sponsors
Novugen Pharma (Malaysia) Sdn. Bhd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Thai male/female must be 18-55 years of age, body weight >50.0 kg with body mass index (BMI) = 18.0-30.0 kg/m2, inclusive. 2. Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 129 mmHg, diastolic blood pressure not lower than 60 or not over 79 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians 3. Screening electrocardiogram (ECG) without clinically significant abnormalities 4. Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr), and liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians. 5. PT and aPTT should be within normal range or showing no clinically significant abnormalities in the opinion of clinical investigator. 6. Thai cardiovascular (CV) risk score must be according to 2016 Royal College of Physicians of Thailand (RCPT) Clinical Practice Guideline on Pharmacologic Therapy of Dyslipidemia for Atherosclerotic Cardiovascular Disease Prevention or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians. Screening visit laboratory values of lipid profile (total cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) will be obtained for low-density lipoprotein cholesterol (LDL-C) and Thai CV risk score calculation. 7. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians. 8. Must have serum hepatitis B surface antigen (HBsAg) seronegative
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to rivaroxaban, any other similar class of drugs or its components 2. Past medical history of renal and hepatic insufficiency 3. Subject has a history of any illness that, in the opinion of principal investigator or designated physicians, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal (especially gastrointestinal ulcer), central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements. 4. Have a history of significant hemorrhage within 6 months 5. Known of coagulation disorders (this may include but is not limited to hemophilia) or sensitive to common cause of bleeding 6. Have condition associated with an increase risk of bleeding. This may include but is not limited to: periodontitis, hemorrhoids acute gastroenteritis and acute peptic ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax pre-dose (duplicate) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 36.00 hours post-dose Rivaroxaban Plasma Concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCs pre-dose (duplicate) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 36.00 hours post-dose Rivaroxaban Plasma Concentration | — |
Countries
Thailand
Contacts
Public ContactAriya Khunvichai
Medica Innova Co., Ltd.
Outcome results
None listed