Delving into the Latest Updates on Tianjin Tasly Shengte Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Nervous System Diseases

Endocrinology and Metabolic Disease

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	1
Neoplasms	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

5-HT2A receptor(Serotonin 2a (5-HT2a) receptor)	1

主要研究目的：研究空腹及餐后状态下单次口服受试制剂酒石酸匹莫范色林片（规格：10 mg/片，天津天士力圣特制药有限公司生产）与参比制剂酒石酸匹莫范色林片（NUPLAZID®，规格：10 mg/片；Acadia Pharmaceuticals Inc生产）在中国健康受试者体内的药代动力学特征，评价空腹及餐后状态下口服两种制剂的生物等效性。次要研究目的：研究空腹及餐后状态下受试制剂酒石酸匹莫范色林片10 mg和参比制剂NUPLAZID® 10 mg在中国健康受试者中的安全性。

[Translation]

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.

Start Date15 Aug 2023

Sponsor / Collaborator

Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

CTR20222456

/ CompletedNot Applicable

酒石酸匹莫范色林胶囊 34 mg随机、开放、两周期、两交叉健康受试者餐后状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of pimavanserin tartrate capsules 34 mg in healthy subjects in the fed state

主要研究目的研究餐后状态下单次口服受试制剂酒石酸匹莫范色林胶囊（规格：34 mg/粒，天津天士力圣特制药有限公司生产）与参比制剂酒石酸匹莫范色林胶囊（NUPLAZID ®，规格：34 mg/粒；Acadia Pharmaceuticals Inc生产）在中国健康受试者体内的药代动力学特征，评价餐后状态下口服两种制剂的生物等效性。次要研究目的研究餐后状态下受试制剂酒石酸匹莫范色林胶囊34 mg和参比制剂NUPLAZID® 34 mg在中国健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic characteristics of the test preparation pimavanserin tartrate capsules (specification: 34 mg/capsule, produced by Tianjin Tasly Saint Pharmaceutical Co., Ltd.) and the reference preparation pimavanserin tartrate capsules (NUPLAZID ®, specification: 34 mg/capsule; produced by Acadia Pharmaceuticals Inc) in healthy Chinese subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives To study the safety of the test preparation pimavanserin tartrate capsules 34 mg and the reference preparation NUPLAZID® 34 mg in healthy Chinese subjects after a meal.

Start Date08 Oct 2022

Sponsor / Collaborator

Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

CTR20222082

/ CompletedNot Applicable

酒石酸匹莫范色林胶囊34 mg随机、开放、两周期、两交叉健康受试者空腹状态下生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of pimavanserin tartrate capsules 34 mg in healthy subjects under fasting conditions

主要研究目的研究空腹状态下单次口服受试制剂酒石酸匹莫范色林胶囊（规格：34 mg/粒，天津天士力圣特制药有限公司生产）与参比制剂酒石酸匹莫范色林胶囊（NUPLAZID ®，规格：34 mg/粒；Acadia Pharmaceuticals Inc生产）在中国健康受试者体内的药代动力学特征，评价空腹状态下口服两种制剂的生物等效性。次要研究目的研究空腹状态下受试制剂酒石酸匹莫范色林胶囊34 mg和参比制剂NUPLAZID® 34 mg在中国健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetic characteristics of the test preparation pimavanserin tartrate capsules (specification: 34 mg/capsule, produced by Tianjin Tasly Saint Pharmaceutical Co., Ltd.) and the reference preparation pimavanserin tartrate capsules (NUPLAZID ®, specification: 34 mg/capsule; produced by Acadia Pharmaceuticals Inc) in healthy Chinese subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary study objectives To study the safety of the test preparation pimavanserin tartrate capsules 34 mg and the reference preparation NUPLAZID® 34 mg in healthy Chinese subjects under fasting conditions.

Start Date22 Sep 2022

Sponsor / Collaborator

Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

100 Clinical Results associated with Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

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100 Deals associated with Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Tianjin Tasly Shengte Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 09 Aug 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3

1

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