Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424381
• Other study ID #: QL-YK4-012-001
• Status: Completed
• Phase: Phase 1
• Start date: June 4, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: June 2020
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 20, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

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:

• Being allergy to the study medications, smoking, alcohol abuse.

• Participation in another clinical trial within 3 months.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	94 days
Primary	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
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	94 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	94 days
Secondary	Incidence of abnormal blood pressure	Monitor the blood pressure	94 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	94 days
Secondary	Incidence of abnormal pulse	Monitor the pulse	94 days
Secondary	Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	94 days