NCT04424381

Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Rivaroxaban 20 MG Oral Tablet [Xarelto]	The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].
DRUG	Rivaroxaban 20 MG Oral Tablet	The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Timeline

• Start date: 2019-06-04
• Primary completion: 2019-09-05
• Completion: 2019-09-20
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: China