Clinical trial NCT04424381: Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers
Official title: Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: rivaroxaban
pharmacokinetics
bioequivalence
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study was designed as a four-period complete and replicate crossover
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 94 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 94 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 94 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 94 days
measure: Incidence of abnormal blood pressure
timeFrame: 94 days
measure: Incidence of abnormal temperature
timeFrame: 94 days
measure: Incidence of abnormal pulse
timeFrame: 94 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 94 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
affiliation: the study director of phase I clinical research center
name: yu Cao
role: PRINCIPAL_INVESTIGATOR
References: