[Translation] A single-center, randomized, open-label, single-dose, two-dose, four-period, fully repeated crossover bioequivalence study to evaluate diclofenac sodium extended-release tablets in healthy adult subjects under fasting and fed conditions
主要研究目的:
考察单次口服(空腹/餐后)100mg受试制剂双氯芬酸钠缓释片和参比制剂VOLTAREN®,在中国成年健康受试者体内的药代动力学特征,初步评估空腹与餐后条件下分别口服两种制剂的生物等效性和个体内变异度。
次要研究目的:
评价单次口服100mg(空腹/餐后)受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of a single oral dose (fasting/postprandial) of 100 mg of the test formulation diclofenac sodium sustained-release tablets and the reference formulation VOLTAREN® in healthy adult Chinese subjects, and to preliminarily evaluate the bioequivalence and intra-individual variability of the two formulations under fasting and postprandial conditions.
Secondary study objectives:
To evaluate the safety of a single oral dose of 100 mg (fasting/postprandial) of the test formulation and the reference formulation in healthy adult Chinese subjects.