Bioequivalence study of dacomitinib and Vizimpro® in healthy Chinese volunteers under fasting and fed conditions: A randomized, open‐label, single‐dose, crossover trial

• Autores principales: Xiaojia Yang (Autor), Jinfang Li (Autor), Taihui Zhang (Autor), Qinping Xia (Autor), Wei Zhang (Autor), Yike Cui (Autor), Wen He (Autor)
• Formato: Libro
• Publicado: Wiley, 2023-12-01T00:00:00Z.
• Materias: article
• Acceso en línea: Connect to this object online.

Abstract This study aimed to evaluate the bioequivalence between test tablet dacomitinib and reference product Vizimpro® under fasting and fed conditions and assess their pharmacokinetic (PK) and safety profiles for gaining marketing approval of the new generic drug. A single‐center, randomized, ope...