Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

• Sponsor: The Affiliated Hospital of Qingdao University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04424381
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]; Drug: Rivaroxaban 20 MG Oral Tablet	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The study was designed as a four-period complete and replicate crossoverThe study was designed as a four-period complete and replicate crossover
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
• Actual Study Start Date: Jun 4, 2019
• Actual Primary Completion Date: Sep 5, 2019
• Actual Study Completion Date: Sep 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rivaroxaban 20 MG Oral Tablet [Xarelto] rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg	Drug: Rivaroxaban 20 MG Oral Tablet; The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
Experimental: Rivaroxaban 20 MG Oral Tablet rivaroxaban oral tablet at a single oral dose of 20 mg	Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]; The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) [94 days]

   Evaluation of Peak Plasma Concentration (Cmax)

2. Area under the plasma concentration versus time curve (AUC)0-t [94 days]

   Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

3. Area under the plasma concentration versus time curve (AUC)0-∞ [94 days]

   Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

Secondary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [94 days]

   Collection of adverse events

2. Incidence of abnormal blood pressure [94 days]

   Monitor the blood pressure

3. Incidence of abnormal temperature [94 days]

   Monitor the temperature

4. Incidence of abnormal pulse [94 days]

   Monitor the pulse

5. Incidence of abnormal electrocardiogram waveform [94 days]

   Electrocardiogram inspection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Clinical Research Center	Qingdao	Shandong	China	266003

Sponsors and Collaborators

• The Affiliated Hospital of Qingdao University

Investigators

• Principal Investigator: yu Cao, the study director of phase I clinical research center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of Qingdao University
• ClinicalTrials.gov Identifier: NCT04424381
• Other Study ID Numbers: QL-YK4-012-001
• First Posted: Jun 11, 2020
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Hospital of Qingdao University: rivaroxaban; pharmacokinetics; bioequivalence
• Additional relevant MeSH terms: Rivaroxaban

Study Results

No Results Posted as of Jun 11, 2020