Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Study Overview
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Brief Summary
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The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.

Detailed Description
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Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.

Official Title
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Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]
* Drug: Rivaroxaban 20 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female aged 18 and above. The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test. The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily. Exclusion Criteria: Being allergy to the study medications, smoking, alcohol abuse. Participation in another clinical trial within 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study was designed as a four-period complete and replicate crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rivaroxaban 20 MG Oral Tablet [Xarelto]<br>rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg | Drug: Rivaroxaban 20 MG Oral Tablet<br>* The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.<br>|
| Experimental: Rivaroxaban 20 MG Oral Tablet<br>rivaroxaban oral tablet at a single oral dose of 20 mg | Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]<br>* The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 94 days | 
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 94 days | 
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 94 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 94 days | 
| Incidence of abnormal blood pressure | Monitor the blood pressure | 94 days | 
| Incidence of abnormal temperature | Monitor the temperature | 94 days | 
| Incidence of abnormal pulse | Monitor the pulse | 94 days | 
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 94 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rivaroxaban, pharmacokinetics, bioequivalence