Rivaroxaban bioequivalence studies

We have conducted in total 5 bioequivalence studies with rivaroxaban. The studies involved cohorts with healthy volunteers, age 18-55, males and females who were admitted to the site for two periods.

 

Rivaroxaban is a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). May also be used as thrombosis prophylaxis in specific situations.

Rivaroxaban is in advanced clinical development for the prevention and treatment of thromboembolic disorders. Oral rivaroxaban may be given in fixed once-daily doses, with the potential for no coagulation monitoring. These properties, along with results from preclinical and clinical studies, suggest that rivaroxaban may have advantages over current treatments. Studies in arterial and venous animal models demonstrated that rivaroxaban has potent antithrombotic effects, without prolonging bleeding times.

 

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News

Christmas wishes

To all our Sponsors, partners, subcontractors and co-workers we would like to wish joyful Christmas and a Happy New Year!

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Participation in NCBiR project

As a Clinical Site we have won a tender for an innovative 1st phase project co-funded by NCBiR.

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GMP Specialist

Ms Dorota Osińska, M.Sc., Pharmacist, QP and experienced auditor, joined BioResearch and started GMP certification process.

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New Clinical Site

We have moved to our new Clinical Site, located in Kajetany, near Warsaw, where 1st phase, BQ and BA studies will be conducted.

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