Delving into the Latest Updates on Valsartan/Levamlodipine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HMK-JST-080, HQ2303, NHKC 1

+ [2]

Target

PLG

Action

stimulants

Mechanism

PLG stimulants(Plasminogen stimulants)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Essential Hypertension

Inactive Indication-

Originator Organization

Beijing Baiao Pharmaceuticals Co., Ltd.

Active Organization

Zhejiang Hemukang Pharmaceutical Technology Co. Ltd.

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.Baicheng Pharmaceutical (Zhuhai Hengqin) Co., Ltd.

+ [2]

Inactive Organization-

License Organization

Zhejiang Anglikang Pharmaceutical Co. Ltd.

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC24H29N5O3

InChIKeyACWBQPMHZXGDFX-QFIPXVFZSA-N

CAS Registry137862-53-4

View All Structures (2)

主要研究目的：评价高脂饮食对中国成年健康受试者单剂量口服NHKC-1片的药代动力学（PK）影响。次要研究目的：评价中国成年健康受试者空腹或餐后单剂量口服NHKC-1片的PK特征。评价中国成年健康受试者单剂量口服NHKC-1片的安全性和耐受性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) effects of a high-fat diet on a single oral dose of NHKC-1 tablets in healthy Chinese adult subjects. Secondary objective: To evaluate the PK characteristics of a single oral dose of NHKC-1 tablets taken in healthy Chinese adult subjects, whether fasting or after a meal. To evaluate the safety and tolerability of a single oral dose of NHKC-1 tablets in healthy Chinese adult subjects.

Start Date12 Jan 2026

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

[+1]

CTR20254639

/ Active, not recruitingNot Applicable

单中心、随机、开放、四周期、四交叉试验评价中国成年健康受试者单次空腹口服NHKC-1、苯磺酸氨氯地平片（络活喜）、缬沙坦片（DIOVAN）、缬沙坦胶囊（代文）的药代动力学比较研究

[Translation] A single-center, randomized, open-label, four-period, four-crossover trial comparing the pharmacokinetics of NHKC-1, amlodipine besylate tablets (Norvasc), valsartan tablets (DIOVAN), and valsartan capsules (Diovan) in healthy adult Chinese subjects after a single fasting oral administration.

主要研究目的：评价中国成年健康受试者单次空腹口服NHKC-1、苯磺酸氨氯地平片（络活喜）、缬沙坦片（DIOVAN）、缬沙坦胶囊（代文）的药代动力学特征、相对生物利用度和相互作用。次要研究目的：评价中国成年健康受试者空腹口服NHKC-1、苯磺酸氨氯地平片（络活喜）、缬沙坦片（DIOVAN）、缬沙坦胶囊（代文）的安全性。

[Translation]

Primary Study Objective: To evaluate the pharmacokinetic characteristics, relative bioavailability, and interactions of a single fasting oral dose of NHKC-1, amlodipine besylate tablets (Norvasc), valsartan tablets (DIOVAN), and valsartan capsules (Diovan) in healthy adult Chinese subjects. Secondary Study Objective: To evaluate the safety of fasting oral administration of NHKC-1, amlodipine besylate tablets (Norvasc), valsartan tablets (DIOVAN), and valsartan capsules (Diovan) in healthy adult Chinese subjects.

Start Date26 Nov 2025

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

[+1]

CTR20244084

/ CompletedPhase 3

一项随机、双盲双模拟、平行对照、多中心临床研究，评价缬沙坦左氨氯地平片治疗轻至中度原发性高血压的有效性和安全性

[Translation] A randomized, double-blind, double-dummy, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of valsartan-amlodipine tablets in the treatment of mild to moderate essential hypertension

1) 评价缬沙坦左氨氯地平片（规格：80mg/2.5mg）治疗轻至中度原发性高血压的有效性； 2) 评价缬沙坦左氨氯地平片（规格：80mg/2.5mg）治疗轻至中度原发性高血压的安全性。

[Translation]

1) To evaluate the effectiveness of valsartan levamlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension; 2) To evaluate the safety of valsartan levamlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension.

Start Date19 Dec 2024

Sponsor / Collaborator

Zhejiang Hemukang Pharmaceutical Technology Co. Ltd.

100 Clinical Results associated with Valsartan/Levamlodipine

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100 Translational Medicine associated with Valsartan/Levamlodipine

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100 Patents (Medical) associated with Valsartan/Levamlodipine

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100 Deals associated with Valsartan/Levamlodipine

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