[Translation] A randomized, open-label, single-center, single-dose, two-formulation, four-period, two-sequence, two-cohort, fully replicated crossover bioequivalence study of diclofenac sodium enteric-coated tablets under fasting and postprandial conditions in healthy adult participants in China.
主要目的
本研究旨在通过两个独立队列,在空腹和餐后条件下,证明双氯芬酸钠肠溶片25 mg(受试制剂)与诺华扶他林25 mg(参比制剂)的生物等效性
次要目的
在两个独立队列中,评估受试制剂与参比制剂在空腹和餐后条件下的药代动力学特征。
在两个独立队列中,评估受试制剂与参比制剂在空腹和餐后条件下的安全性特征。
[Translation] Primary Objective: This study aims to demonstrate the bioequivalence of diclofenac sodium enteric-coated tablets 25 mg (test formulation) and Novartis diclofenac sodium 25 mg (reference formulation) under fasting and postprandial conditions in two independent cohorts.
Secondary Objectives: To evaluate the pharmacokinetic characteristics of the test and reference formulations under fasting and postprandial conditions in two independent cohorts.
To evaluate the safety characteristics of the test and reference formulations under fasting and postprandial conditions in two independent cohorts.