Delving into the Latest Updates on Daito 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	2
Immune System Diseases	1
Infectious Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

COXs(Cyclooxygenases)	1
DDC x DRDs	1

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服塞来昔布胶囊受试制剂（规格：200mg，申办者：大桐制药（中国）有限责任公司）和参比制剂（商品名：西乐葆®，规格：0.2g，持证商：G.D.Searle LLC）后的药代动力学特点和生物等效性。次要研究目的研究塞来昔布胶囊受试制剂（规格：200mg）和参比制剂（西乐葆®，规格：0.2g）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of celecoxib capsules (specification: 200 mg, applicant: Datong Pharmaceutical (China) Co., Ltd.) and the reference formulation (trade name: Celebrex®, specification: 0.2 g, licensee: G.D.Searle LLC) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of celecoxib capsules (specification: 200 mg) and the reference formulation (Celebrex®, specification: 0.2 g) in healthy Chinese adult subjects.

Start Date16 Oct 2023

Sponsor / Collaborator

Daito Pharmaceutical (CHINA) Co., Ltd.

CTR20230539

/ CompletedNot Applicable

普瑞巴林胶囊在中国健康成年受试者中单次空腹及餐后口服给药的一项单中心、随机、开放、双制剂、双周期、双序列、交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, crossover bioequivalence study of pregabalin capsules in healthy Chinese adult subjects after single oral administration on an empty stomach or after a meal

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服普瑞巴林胶囊受试制剂（规格：150mg，申办者：大桐制药（中国）有限责任公司）和参比制剂（商品名：乐瑞卡®，规格：150mg，持证商：Pfizer Europe MA EEIG）后的药代动力学特点和生物等效性。次要研究目的研究普瑞巴林胶囊受试制剂（规格：150mg）和参比制剂（乐瑞卡®，规格：150mg）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of pregabalin capsules (specification: 150 mg, applicant: Datong Pharmaceutical (China) Co., Ltd.) and the reference formulation (trade name: Lyrica®, specification: 150 mg, licensee: Pfizer Europe MA EEIG) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of pregabalin capsules (specification: 150 mg) and the reference formulation (Lyrica®, specification: 150 mg) in healthy Chinese adult subjects.

Start Date10 May 2023

Sponsor / Collaborator

Daito Pharmaceutical (CHINA) Co., Ltd.

100 Clinical Results associated with Daito Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Daito Pharmaceutical Co., Ltd.

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100 Deals associated with Daito Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Daito Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 25 Dec 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

NDA/BLA

1

Approved

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