A single-dose, randomized, open-label, four-period, crossover equivalence trial comparing the clinical similarity of the proposed biosimilar rupatadine fumarate to reference Wystamm® in healthy Chinese subjects

• Main Authors: Sisi Lin (Author), Yutao Lou (Author), Rui Hao (Author), Yiming Shao (Author), Jin Yu (Author), Lu Fang (Author), Meihua Bao (Author), Wu Yi (Author), Yiwen Zhang (Author)
• Format: Book
• Published: Frontiers Media S.A., 2024-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

PurposeThe aim of this study was to evaluate the bioequivalence of two formulations of rupatadine (10-mg tablets) under fasting and fed conditions in healthy Chinese subjects.MethodsA total of 72 subjects were randomly assigned to the fasting cohort (n = 36) and fed cohort (n = 36). Each cohort incl...