[Translation] Bioequivalence study of apremilast tablets in healthy subjects after single oral administration on an empty stomach/after meal, randomized, open, two-sequence, two-period crossover, self-control
通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单剂量口服成都百裕制药股份有限公司生产的阿普米司特片(30mg)与持证商Amgen Europe B.V.的阿普米司特片(30mg)后的体内药代动力学特征,评价两制剂的生物等效性。
[Translation] Through the fasting/postprandial study, it was investigated that Chinese healthy subjects took a single dose of apremilast tablets (30mg) produced by Chengdu Baiyu Pharmaceutical Co., Ltd. The in vivo pharmacokinetic characteristics of Primimilast tablets (30mg) were evaluated to evaluate the bioequivalence of the two preparations.