NCT04753489

Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions

Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 10mg (Pharmtechnology LLC, Republic of Belarus) and Xarelto® Film-coated Tablets 10mg (Bayer AG, Germany) in Healthy Male Volunteers in Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Rivaroxaban film-coated tablet 10 mg	Rivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of rivaroxaban.
DRUG	Xarelto® film-coated tablet 10 mg	Xarelto® is manufactured by Bayer AG, Germany. Each tablet contains 10 mg of rivaroxaban.

Timeline

• Start date: 2021-02-13
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2021-02-15
• Last updated: 2021-02-15

Locations

1 site across 1 country: Russia