Testing antiplatelets generics beyond bioequivalence: A parallel single-blinded randomized trial

Résumé

Abstract Purpose Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily therapeutically equivalent. The aim of our study is to introduce the concept of “studying the clinical effectiveness” of generic drug in comparison to the brand drug rather than simply comparing “their bioequivalence” to build more trust to use the generic drug. This study was conducted to prove the efficacy and safety of ticagrelor - generically named as Ticaloguard® compared to its brand Brilique® in heathy volunteers. Methods A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Tica and Brili groups, respectively. The platelet aggregation on ADP agonist was assessed at different time intervals. Results It was shown that generic Ticaloguard® provides a similar therapeutic effect and safety as its branded Brilique® (p > 0.05). Conclusion The present study revealed that the antiplatelet inhibition activity and safety of the generic ticagrelor (Ticalogaurd®) are comparable to its brand Brilique® in healthy volunteers.Testing generic drug effects rather than simple bioequivalency, especially for drugs that are used in critical life-threatening situations, is crucial. We advocate applying this form of a clinical trial to test surrogate clinical efficacy for generics used in critical indications before having real-world data whenever possible.

Citer ce document

Accès au document

Ce document est hébergé sur son dépôt institutionnel d'origine.

Auteur(s)

Statistiques

Consultations : 1

Téléchargements : 0