Delving into the Latest Updates on Chia Tai Pharmaceutical (Qingdao) Co., Ltd. with Synapse

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主要目的：以中国健康受试者为试验对象，采用随机、开放、两周期、两序列、双交叉试验设计，考察健康受试者空腹及餐后单次口服由正大天晴药业集团股份有限公司生产（青岛国信制药有限公司持证）的磷酸芦可替尼片（受试制剂，规格：20mg，以芦可替尼计）与 Novartis Farmacéutica S.A.生产（Novartis Europharm Limited 持证）的磷酸芦可替尼片（参比制剂，商品名：Jakavi®，规格：20mg，以芦可替尼计）后芦可替尼的体内经时过程，评价空腹及餐后状态下制剂间的生物等效性。次要目的：评价磷酸芦可替尼片受试制剂和参比制剂（商品名： Jakavi®）在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo time course of ruxolitinib in healthy subjects after taking a single oral dose of ruxolitinib phosphate tablets (test preparation, specification: 20 mg, calculated as ruxolitinib) produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (licensed by Qingdao Guoxin Pharmaceutical Co., Ltd.) and ruxolitinib phosphate tablets (reference preparation, trade name: Jakavi®, specification: 20 mg, calculated as ruxolitinib) produced by Novartis Farmacéutica S.A. (licensed by Novartis Europharm Limited) in fasting and postprandial state using a randomized, open, two-period, two-sequence, double-crossover design, and to evaluate the bioequivalence between the preparations in fasting and postprandial state. Secondary objective: To evaluate the safety of the test preparation and reference preparation (trade name: Jakavi®) of ruxolitinib phosphate tablets in healthy subjects.

Start Date05 Oct 2024

Sponsor / Collaborator

Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

CTR20231594 / CompletedPhase 1

注射用 BG136 在健康受试者中首次人体、随机、双盲、安慰剂对照、单次剂量递增和多次剂量递增的 I 期临床试验

[Translation] A first-in-human, randomized, double-blind, placebo-controlled, single-ascending and multiple-ascending doses phase I clinical trial of BG136 for injection in healthy subjects

主要目的：评估注射用BG136在健康受试者中单次和多次静脉滴注给药的安全性和耐受性。次要目的：评估健康受试者单次和多次静脉滴注注射用BG136的药代动力学（PK）和药效动力学（PD）特征；评估注射用BG136在健康受试者体内安全有效的剂量范围，为Ⅱ期临床研究的给药方案提供依据；评估注射用BG136在健康受试者体内免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of single and multiple intravenous infusions of BG136 for injection in healthy subjects. Secondary objectives: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single and multiple intravenous infusions of BG136 for injection in healthy subjects; To evaluate the safe and effective dose range of BG136 for injection in healthy subjects, and provide a basis for the dosing regimen of Phase II clinical studies; To evaluate the immunogenicity of BG136 for injection in healthy subjects.

Start Date19 Aug 2023

Sponsor / Collaborator

Ocean University of China

[+2]

CTR20231261 / CompletedNot Applicable

艾地骨化醇软胶囊在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of idecalcitol soft capsules in healthy Chinese adult subjects

主要研究目的：考察空腹/餐后条件下单次口服0.5μg受试制剂艾地骨化醇软胶囊（规格：0.5μg/粒，正大制药（青岛）有限公司生产）与参比制剂艾地骨化醇软胶囊（商品名：EDIROL®，规格：0.5μg/粒，中外製薬株式会社生产）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态分别口服两种制剂的生物等效性。次要研究目的：评价受试制剂和参比制剂空腹/餐后条件下单次口服0.5μg在中国成年健康受试者中的安全性。

[Translation]

Main research purpose: To investigate the single oral administration of 0.5 μg test preparation idecalcidol soft capsule (specification: 0.5 μg/capsule, produced by Chia Tai Pharmaceutical (Qingdao) Co., Ltd.) and the reference preparation idecalcitol under fasting/postprandial conditions. Pharmacokinetic characteristics of Huachol Soft Capsule (trade name: EDIROL®, specification: 0.5 μg/capsule, produced by Chugai Seiko Co., Ltd.) in Chinese adult healthy subjects were evaluated after oral administration in fasting and postprandial states. Bioequivalence of formulations. Secondary study purpose: To evaluate the safety of a single oral dose of 0.5 μg of the test preparation and reference preparation in Chinese adult healthy subjects under fasting/postprandial conditions.

Start Date21 May 2023

Sponsor / Collaborator

Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

100 Clinical Results associated with Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

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0 Patents (Medical) associated with Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

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1

Literatures (Medical) associated with Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

Chinese Journal of New Drugs

Research and development of marine drugs

Author: Ren, Li ; Chen, Yang-sheng

A review.This text summarizes the research actuality and the basic studying methods of marine medicines in the near years.It puts forward some opinions and suggestion to the R&D of the marine medicines.At the same time this text gives some prospect on the development of marine medicines.

100 Deals associated with Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

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100 Translational Medicine associated with Chia Tai Pharmaceutical (Qingdao) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

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 1

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