check_circleStudy Completed

Therapeutic Equivalency

Bayer Identifier:

14588

ClinicalTrials.gov Identifier:

NCT01436526

EudraCT Number:

2009-013032-20

EU CT Number:

Not Available
Bioequivalence study in healthy subjects, 2*5 mg tablets Rivaroxaban versus 1*10 mg tablet Rivaroxaban

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

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

Enrollment Goal
28
Trial Dates
August 2009 - September 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • Area under the plasma concentration versus time curve from time zero to infinity after single dose (AUC) incl. bioequivalence (BE) evaluation
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration versus time curve from time zero to last quantifiable concentration [AUC (0-tn)] incl. bioequivalence (BE) evaluation
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration in plasma after single dose administration (Cmax) incl. bioequivalence (BE) evaluation
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Area under the plasma concentration versus time curve divided by dose per kg body weight (AUCnorm)
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration in plasma after single dose administration divided by dose per kg body weight (Cmax, norm)
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Mean residence time (MRT)
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Time to reach maximum drug concentration in plasma after single dose (tmax)
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No
  • Half-life associated with the terminal slope (t½)
    date_rangeTime Frame:
    0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration
    enhanced_encryption
    Safety Issue:
    No

Trial design

Single-dose, open-label, randomized, 2-way crossover pivotal bioequivalence study of 2x5 mg tablets Rivaroxaban versus 1x10 mg tablet Rivaroxaban under fasted condition in healthy subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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