Delving into the Latest Updates on Shihuida Pharmaceutical Group (Jilin) Co., Ltd. with Synapse

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Cardiovascular Diseases

Small molecule drug

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Top 5 Drug Type	Count

Small molecule drug	1

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L-type calcium channel x β-adrenoceptors	1

[Translation] A multicenter, randomized, double-blind, double-dummy, active drug-controlled, parallel-design phase III clinical trial to evaluate the efficacy of levamlodipine-bisoprolol tablets in the treatment of primary hypertension with poor blood pressure control after monotherapy with levamlodipine besylate tablets or bisoprolol fumarate tablets

评价左氨氯地平比索洛尔片在苯磺酸左氨氯地平片或富马酸比索洛尔片单药治疗后血压控制不佳的原发性高血压患者中的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of levoamlodipine-bisoprolol tablets in patients with essential hypertension whose blood pressure is poorly controlled after monotherapy with levoamlodipine besylate tablets or bisoprolol fumarate tablets.

Start Date21 Feb 2024

Sponsor / Collaborator

Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

CTR20231792

/ CompletedPhase 1

左氨氯地平比索洛尔片在健康受试者中单中心、随机、开放、三制剂、单次给药、两周期、双交叉空腹/餐后药代动力学试验

[Translation] A single-center, randomized, open-label, three-dose, single-dose, two-period, double-crossover fasting/postprandial pharmacokinetic study of levoamlodipine-bisoprolol tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下单次口服受试制剂T左氨氯地平比索洛尔片（规格：2.5mg/5mg（以左氨氯地平/富马酸比索洛尔计），生产厂家：施慧达药业集团（吉林）有限公司）与对照制剂R1苯磺酸左氨氯地平片（规格：2.5mg（以左氨氯地平计），持证商：施慧达药业集团（吉林）有限公司，商品名：施慧达®）、R2富马酸比索洛尔片（规格：5mg，持证商：默克制药（江苏）有限公司，商品名：康忻®）联合给药在健康受试者体内的药代动力学行为，以验证复方制剂左氨氯地平比索洛尔片与单药苯磺酸左氨氯地平片、富马酸比索洛尔片联合用药在健康受试者体内吸收速度和程度是否一致。次要目的：观察单次口服受试制剂T左氨氯地平比索洛尔片在健康受试者中的安全性。

[Translation]

Main objective: To compare the pharmacokinetic parameters as the primary endpoint evaluation indicators, and to compare the pharmacokinetic behavior of the test preparation T levamlodipine bisoprolol tablets (specification: 2.5mg/5mg (calculated as levamlodipine/bisoprolol fumarate), manufacturer: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd.) and the control preparations R1 levamlodipine besylate tablets (specification: 2.5mg (calculated as levamlodipine), license holder: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd., trade name: Shi Huida®) and R2 bisoprolol fumarate tablets (specification: 5mg, license holder: Merck Pharmaceuticals (Jiangsu) Co., Ltd., trade name: Kangxin®) in healthy subjects after a single oral administration in the fasting/postprandial state, so as to verify whether the absorption rate and extent of the combination preparation levamlodipine bisoprolol tablets and the single drug levamlodipine besylate tablets and bisoprolol fumarate tablets are consistent in healthy subjects. Secondary objective: To observe the safety of a single oral administration of the test formulation T levamlodipine bisoprolol tablets in healthy subjects.

Start Date14 Aug 2023

Sponsor / Collaborator

Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

CTR20231791

/ CompletedPhase 1

左氨氯地平比索洛尔片在健康受试者中单中心、随机、开放、三制剂、单次给药、两周期、双交叉空腹/餐后药代动力学试验研究方案

[Translation] Study plan for a single-center, randomized, open-label, three-dose, single-dose, two-period, double-crossover fasting/postprandial pharmacokinetic trial of levoamlodipine-bisoprolol tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下单次口服受试制剂T左氨氯地平比索洛尔片（规格：2.5mg/2.5mg（以左氨氯地平/富马酸比索洛尔计），生产厂家：施慧达药业集团（吉林）有限公司）与对照制剂R1苯磺酸左氨氯地平片（规格：2.5mg（以左氨氯地平计），持证商：施慧达药业集团（吉林）有限公司，商品名：施慧达®）、R2富马酸比索洛尔片（规格：2.5mg，持证商：Merck Healthcare Germany GmbH，商品名：Concor®）联合给药在健康受试者体内的药代动力学行为，以验证复方制剂左氨氯地平比索洛尔片给药与单药苯磺酸左氨氯地平片、富马酸比索洛尔片联合用药在健康受试者体内吸收速度和程度是否一致。次要目的：观察单次口服受试制剂T左氨氯地平比索洛尔片在健康受试者中的安全性。

[Translation]

Main objective: To compare the pharmacokinetic parameters as the primary endpoint evaluation indicators in the pharmacokinetic behavior of the test preparation T levamlodipine bisoprolol tablets (specification: 2.5mg/2.5mg (calculated as levamlodipine/bisoprolol fumarate), manufacturer: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd.) and the control preparations R1 levamlodipine besylate tablets (specification: 2.5mg (calculated as levamlodipine), licensee: Shi Huida Pharmaceutical Group (Jilin) Co., Ltd., trade name: Shi Huida®) and R2 bisoprolol fumarate tablets (specification: 2.5mg, licensee: Merck Healthcare Germany GmbH, trade name: Concor®) in healthy subjects after a single oral administration in the fasting/postprandial state, so as to verify whether the absorption rate and extent of the combination of the compound preparation levamlodipine bisoprolol tablets and the single drug levamlodipine besylate tablets and bisoprolol fumarate tablets are consistent in healthy subjects. Secondary objective: To observe the safety of a single oral administration of the test formulation T levamlodipine bisoprolol tablets in healthy subjects.

Start Date20 Jul 2023

Sponsor / Collaborator

Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

100 Clinical Results associated with Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

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0 Patents (Medical) associated with Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

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100 Deals associated with Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

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100 Translational Medicine associated with Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 15 Jan 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 Clinical

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