[Translation] Bioequivalence study of diclofenac sodium extended-release tablets (0.1 g) in healthy subjects in a randomized, open-label, four-cycle, two-sequence, fully replicated crossover single-shot fasting/prandial state
主要目的:空腹/餐后条件下考察受试制剂和参比制剂在健康男性与女性受试者中的生物等效性。
次要目的:观察受试制剂与参比制剂在健康受试者中的安全性。
[Translation] Main purpose: To investigate the bioequivalence of the test preparation and the reference preparation in healthy male and female subjects under fasting/postprandial conditions.
Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects.