Status:
COMPLETED
Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 t...
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 lea...
Eligibility Criteria
Inclusion
- 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
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04424381
Start Date
June 4 2019
End Date
September 20 2019
Last Update
June 11 2020
Active Locations (1)
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1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003