Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

Primary study objective: To evaluate the efficacy of 34 mg pimavanserin tartrate capsules in the treatment of patients with psychotic symptoms in Parkinson's disease. Secondary study objective: To evaluate the safety of 34 mg pimavanserin tartrate capsules in the treatment of patients with psychotic symptoms in Parkinson's disease.

Main study objectives: To study the pharmacokinetic characteristics of the test preparation pimavanserin tartrate tablets (specification: 10 mg/tablet, produced by Tianjin Tasly Saint Pharmaceutical Co., Ltd.) and the reference preparation pimavanserin tartrate tablets (NUPLAZID®, specification: 10 mg/tablet; produced by Acadia Pharmaceuticals Inc) in Chinese healthy subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state. Secondary study objectives: To study the safety of the test preparation pimavanserin tartrate tablets 10 mg and the reference preparation NUPLAZID® 10 mg in Chinese healthy subjects in fasting and fed state.

Main study objectives: To study the pharmacokinetic characteristics of the test preparation pimavanserin tartrate tablets (specification: 10 mg/tablet, produced by Tianjin Tasly Saint Pharmaceutical Co., Ltd.) and the reference preparation pimavanserin tartrate tablets (NUPLAZID®, specification: 10 mg/tablet; produced by Acadia Pharmaceuticals Inc) in Chinese healthy subjects after single oral administration in fasting and fed state, and to provide reference for formal evaluation of the bioequivalence of the two preparations in fasting and fed state. Secondary study objectives: To study the safety of the test preparation pimavanserin tartrate tablets 10 mg and the reference preparation NUPLAZID® 10 mg in Chinese healthy subjects in fasting and fed state.