A Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 20 mg in Healthy Thai Volunteers under Fed Conditions

Phase 1

Completed

• Conditions: Healthy volunteers; Bioequivalence; Rivaroxaban; Pharmacokinetics

• Registration Number: TCTR20211203004
• Lead Sponsor: ovugen Pharma (Malaysia) Sdn. Bhd

Brief Summary

Rivaroxaban Film-Coated Tablets 20 mg is bioequivalent to Xarelto 20 mg

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study Completion: 2022-04-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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