Therapeutic Equivalency Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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