Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2019-09-20

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.

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study was designed as a four-period complete and replicate crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rivaroxaban 20 MG Oral Tablet

rivaroxaban oral tablet at a single oral dose of 20 mg

Group Type EXPERIMENTAL

Rivaroxaban 20 MG Oral Tablet [Xarelto]

Intervention Type DRUG

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].

Rivaroxaban 20 MG Oral Tablet [Xarelto]

rivaroxaban oral tablet \[Xarelto\] at a single oral dose of 20 mg

Group Type ACTIVE_COMPARATOR

Rivaroxaban 20 MG Oral Tablet

Intervention Type DRUG

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Interventions

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Rivaroxaban 20 MG Oral Tablet [Xarelto]

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].

Intervention Type DRUG

Rivaroxaban 20 MG Oral Tablet

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Intervention Type DRUG

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.