[Translation] A randomized, open-label, two-dose, single-dose, four-cycle, two-sequence, fully repeated, fasting and fed bioequivalence study of diclofenac sodium extended-release tablets in healthy subjects
主要目的:评价健康受试者在空腹和餐后状态下口服天津梅花生物医药科技有限公司生产的受试制剂双氯芬酸钠缓释片与Novartis Pharma S.A.S.持有的参比制剂双氯芬酸钠缓释片(Voltarene® LP)后的生物等效性。
次要目的:观察受试制剂双氯芬酸钠缓释片与参比制剂双氯芬酸钠缓释片(Voltarene® LP)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation diclofenac sodium sustained-release tablets produced by Tianjin Meihua Biopharmaceutical Technology Co., Ltd. and the reference preparation diclofenac sodium sustained-release tablets (Voltarene® LP) held by Novartis Pharma S.A.S. in healthy subjects after oral administration in fasting and fed state.
Secondary objective: To observe the safety of the test preparation diclofenac sodium sustained-release tablets and the reference preparation diclofenac sodium sustained-release tablets (Voltarene® LP) in healthy subjects.