[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover, fasting-administered bioequivalence study of efavirenz tablets in humans
本试验旨在研究健康受试者单次空腹口服东北制药集团沈阳第一制药有限公司研制、生产的依非韦伦片(0.2 g)的药代动力学特征;以MSD株式会社生产的依非韦伦片(STOCRIN®,200 mg)为参比制剂,比较两制剂中药动学参数Cmax和AUC0-72,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] This trial aims to study the pharmacokinetic characteristics of healthy subjects taking a single fasting oral administration of efavirenz tablets (0.2 g) developed and produced by Northeast Pharmaceutical Group Shenyang Daiichi Pharmaceutical Co., Ltd.; Wellen Tablets (STOCRIN®, 200 mg) is a reference preparation. Compare the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy subjects. sex.