[Translation] A randomized, open-label, three-sequence, three-period, partially repeated crossover bioequivalence study of a single oral fasting dose of valsartan-levoamlodipine tablets compared with valsartan tablets (DIOVAN®) and amlodipine besylate tablets (Norvasc®) in healthy subjects

研究空腹状态下单次口服受试制剂缬沙坦左氨氯地平片（规格：80 mg/2.5 mg）与参比制剂缬沙坦片（DIOVAN®，规格：80 mg）、苯磺酸氨氯地平片（络活喜®，规格：5 mg）在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评估空腹状态口服两种制剂的生物等效性，为该药的申报及临床用药提供参考依据。

[Translation]

The relative bioavailability of a single oral dose of the test preparation valsartan levoamlodipine tablets (specification: 80 mg/2.5 mg) and the reference preparations valsartan tablets (DIOVAN®, specification: 80 mg) and amlodipine besylate tablets (Norvasc®, specification: 5 mg) in healthy Chinese subjects under fasting conditions was studied, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations taken orally under fasting conditions was evaluated, so as to provide a reference for the application and clinical use of the drug.

Start Date20 Sep 2024

Sponsor / Collaborator

Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.

CTR20242169 / RecruitingPhase 3

缬沙坦左氨氯地平片（80mg /2.5mg）用于缬沙坦胶囊（80mg）或苯磺酸氨氯地平片（5mg）单药治疗4 周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性的随机、双盲双模拟、阳性药平行对照、多中心III期临床研究

[Translation] A randomized, double-blind, double-dummy, active drug parallel-controlled, multicenter phase III clinical study on the efficacy and safety of valsartan-levoamlodipine tablets (80mg/2.5mg) compared with valsartan capsules (80mg) or amlodipine besylate tablets (5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy.

验证复方制剂相对于单方制剂的优效性评价缬沙坦左氨氯地平片（80mg/2.5mg）用于缬沙坦胶囊（80mg）或苯磺酸氨氯地平片（5mg）单药治疗4 周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性。

[Translation]

To verify the superiority of the combination preparation over the single preparation and to evaluate the efficacy and safety of valsartan levoamlodipine tablets (80mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy with valsartan capsules (80mg) or amlodipine besylate tablets (5mg).

Start Date24 Jul 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20241533 / RecruitingPhase 3

以24 小时动态血压监测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的多中心临床研究

[Translation] A multicenter clinical study evaluating the efficacy and safety of valsartan-amlodipine tablets in the treatment of mild to moderate essential hypertension using 24-hour ambulatory blood pressure monitoring

以24小时动态血压监测（ABPM）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；以24小时动态血压监测（ABPM）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]

To evaluate the effectiveness of valsartan-amlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension by 24-hour ambulatory blood pressure monitoring (ABPM); To evaluate the safety of valsartan-amlodipine tablets (specification: 80mg/2.5mg) in the treatment of mild to moderate essential hypertension by 24-hour ambulatory blood pressure monitoring (ABPM).

Start Date19 Jul 2024

Sponsor / Collaborator

Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Valsartan/Levamlodipine

100 Translational Medicine associated with Valsartan/Levamlodipine

100 Patents (Medical) associated with Valsartan/Levamlodipine

100 Deals associated with Valsartan/Levamlodipine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 3	CN	Beijing Baiao Pharmaceuticals Co., Ltd.	13 Mar 2023

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