[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of pimavanserin tartrate capsules in Chinese healthy volunteers under fasting and fed conditions
研究健康受试者空腹及餐后单次口服受试制剂酒石酸匹莫范色林胶囊(浙江佰奥医药科技有限公司,规格:34mg)与参比制剂酒石酸匹莫范色林胶囊(商品名:Nuplazid®,规格:34mg)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和餐后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受试者中的安全性。
[Translation] To investigate whether there are differences in the extent and rate of absorption of the test preparation pimavanserin tartrate capsules (Zhejiang Biopharma Technology Co., Ltd., specification: 34 mg) and the reference preparation pimavanserin tartrate capsules (trade name: Nuplazid®, specification: 34 mg) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.