Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Phase 1

Completed

Interventions: Drug: Rivaroxaban 20 MG Oral Tablet
Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rivaroxaban 20 MG Oral Tablet [Xarelto]	Rivaroxaban 20 MG Oral Tablet	rivaroxaban oral tablet \[Xarelto\] at a single oral dose of 20 mg
Rivaroxaban 20 MG Oral Tablet	Rivaroxaban 20 MG Oral Tablet [Xarelto]	rivaroxaban oral tablet at a single oral dose of 20 mg

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)0-∞	94 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)	94 days	Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t	94 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal pulse	94 days	Monitor the pulse
Incidence of abnormal temperature	94 days	Monitor the temperature
Incidence of abnormal electrocardiogram waveform	94 days	Electrocardiogram inspection
Incidence of Treatment-Emergent Adverse Events	94 days	Collection of adverse events
Incidence of abnormal blood pressure	94 days	Monitor the blood pressure

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