Journal of Bioequivalence & Bioavailability

Ferrer Internacional S.A. (Ferrer Grupo), Barcelona, Spain

Publications

• Research Article   
  Single Dose Bioequivalence Study of Two Rivaroxaban Tablet Formulations, Administered Orally after Being Crushed and Suspended in Apple Puree
  Author(s): Simona Nicoleta Duna*, Adrian Ghita, Adelina Ciuciuleaca, Irene Manzanera, David Puibert and Simona Rizea-Savu
  
  The bioavailability of an active substance might be altered when a solid oral dosage form (SODF) is crushed or disintegrated and mixed with fluids or food in order to assist swallowing. In consequence, the current European Medicines Agency (EMA) practice is to request comparative bioavailability testing for bridging safety and efficacy data from a formulation administered whole to the same product administered crushed. Specific criteria for waiving in vivo testing of crushed products are available only for BCS Class I and Class III drugs. Since rivaroxaban is a Class II drug which can be administered crushed and mixed with fluids, any generic formulation has to be tested against the originator in this setting. Therefore, an open label, randomized, single dose, two-period, two-sequence, crossover bioequivalence study with administration of rivaroxaban 10 mg crushed ta.. View more»
  

  DOI: 10.35248/0975-0851.19.11.388

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