Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
Condition: Therapeutic Equivalency
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939)
Intervention 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); 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)
Intervention MeSH terms: Rivaroxaban
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence

Summary:

      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.
    

Eligibility criteria:

        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