Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban

Bayer

Status and phase: Completed; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436526

2009-013032-20 (EudraCT Number)

14588

Details and patient eligibility

About

The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.

Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.

The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects
• 18 to 45 years of age
• Body mass index (BMI) between 18 and 30 kg/m2

Exclusion criteria

• Conspicuous findings (medical history, screening)
• History of relevant diseases (internal organs, central nervous system or other organs)
• Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
• Febrile illness within 1 week before the start of the study
• History of severe allergies, non-allergic drug reactions, or multiple drug allergies
• Hypersensitivity to the investigational drug, the control agent and/or to inactive constituents
• Known coagulation disorders, known disorders with increased bleeding risk, known sensitivity to common causes of bleeding

Trial design

28 participants in 2 patient groups

Rivaroxaban (Xarelto, BAY59-7939) first 2*5 mg, then 1*10 mg

Experimental group

Description:

Single oral dose of rivaroxaban administered under fasting conditions 2\*5 mg tablet in first intervention period and 1\*10 mg tablet in second intervention period (after washout period)

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban (Xarelto, BAY59-7939) first 1*10 mg, then 2*5 mg

Experimental group

Description:

Single oral dose of rivaroxaban administered under fasting conditions 1\*10 mg tablet in first intervention period and 2\*5 mg tablet in second intervention period (after washout period)

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Rivaroxaban (Xarelto, BAY59-7939)