[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, two-cycle, two-crossover human bioequivalence trial of zopiclone capsules administered orally to Chinese healthy participants under fasting conditions.
研究健康试验参与者空腹单次口服受试制剂佐匹克隆胶囊(天津华津制药有限公司,规格:7.5mg)与参比制剂佐匹克隆片(商品名:Imovane®,Sanofi-Aventis France,规格:7.5mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹状态下给药时的生物等效性,观察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] This study investigates whether there are differences in the extent and rate of absorption between the test formulation zopiclone capsules (Tianjin Huajin Pharmaceutical Co., Ltd., specification: 7.5 mg) and the reference formulation zopiclone tablets (trade name: Imovane®, Sanofi-Aventis France, specification: 7.5 mg) administered orally in healthy participants on an empty stomach, evaluates the bioequivalence of the test and reference formulations when administered on an empty stomach, and observes the safety of the test and reference formulations in healthy participants.