Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Qingdao University

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Rivaroxaban 20 MG Oral Tablet; Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]

Study type: Interventional

Funder types: Other

Identifiers

NCT04424381

QL-YK4-012-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Rivaroxaban 20 MG Oral Tablet [Xarelto]

Active Comparator group

Description:

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

Treatment:

Drug: Rivaroxaban 20 MG Oral Tablet

Rivaroxaban 20 MG Oral Tablet

Experimental group

Description:

rivaroxaban oral tablet at a single oral dose of 20 mg

Treatment:

Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]