Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency
Intervention: Rivaroxaban (Xarelto, BAY59-7939) (Drug); Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) EvaluationArea Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation
Secondary outcome: Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm) Mean Residence Time (MRT) Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax) Half-life Associated With the Terminal Slope (t½)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
Mönchengladbach, Nordrhein-Westfalen 41061, Germany
Additional Information
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Starting date: August 2009
Last updated: April 2, 2015
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