[Translation] A single-center, single-dose oral, randomized, open-label, two-drug, three-cycle, semi-repetitive crossover bioequivalence study of diclofenac sodium extended-release tablets in healthy subjects
主要目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单次口服受试制剂双氯芬酸钠缓释片(规格:0.1g,德州德药制药有限公司提供)与参比制剂双氯芬酸钠缓释片(商品名: VOLTAREN®,规格:100mg,Novartis Pharma GmbH生产)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单次口服双氯芬酸钠缓释片受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Through the fasting/postprandial experimental study, to investigate the relationship between a single oral dose of the test preparation Diclofenac Sodium Sustained-release Tablets (specification: 0.1g, provided by Dezhou Deyao Pharmaceutical Co., Ltd.) in Chinese healthy subjects under fasting/postprandial conditions. The in vivo pharmacokinetic characteristics of the reference preparation diclofenac sodium sustained-release tablets (trade name: VOLTAREN®, strength: 100 mg, produced by Novartis Pharma GmbH), and the bioequivalence of the two preparations was evaluated.
Secondary objective: To evaluate the safety of a single oral dose of diclofenac sodium sustained-release tablet test preparation and reference preparation in healthy Chinese subjects.