[Translation] A single-center, randomized, open-label, fasting and fed single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of NHKC-1 in healthy adult Chinese subjects

要研究目的：考察空腹/餐后单次口服受试制剂NHKC-1（规格：每片含80 mg缬沙坦和2.5 mg左氨氯地平，江苏永安制药有限公司生产）与参比制剂【苯磺酸氨氯地平片（络活喜）5 mg和缬沙坦片（Diovan）80 mg各1片】，在中国成年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，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Primary study purpose: To investigate the relative bioavailability of the single oral administration of the test preparation NHKC-1 (specification: each tablet contains 80 mg valsartan and 2.5 mg levoamlodipine, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) on an empty stomach/after a meal and the reference preparation [1 tablet each of amlodipine besylate tablets (Norvasc) 5 mg and valsartan tablets (Diovan) 80 mg] in healthy Chinese adults, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study purpose: To evaluate the safety of the single oral administration of the test preparation and the reference preparation on an empty stomach/after a meal in healthy Chinese adults.

Start Date26 Nov 2024

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

[+1]

CTR20243322 / RecruitingPhase 3

评价 NHKC-1用于苯磺酸左氨氯地平片单药治疗4周后血压不能控制的原发性轻、中度高血压患者的有效性和安全性研究

[Translation] To evaluate the efficacy and safety of NHKC-1 in patients with primary mild to moderate hypertension whose blood pressure cannot be controlled after 4 weeks of monotherapy with levamlodipine besylate tablets

主要目的：评价 NHKC-1用于苯磺酸左氨氯地平片单药治疗4周后血压控制不佳的原发性轻、中度高血压患者的有效性。次要目的：评价 NHKC-1用于苯磺酸左氨氯地平片单药治疗4周后血压控制不佳的原发性轻、中度高血压患者的安全性。

[Translation]

Primary objective: To evaluate the efficacy of NHKC-1 in patients with primary mild to moderate hypertension whose blood pressure is poorly controlled after 4 weeks of monotherapy with levamlodipine besylate tablets. Secondary objective: To evaluate the safety of NHKC-1 in patients with primary mild to moderate hypertension whose blood pressure is poorly controlled after 4 weeks of monotherapy with levamlodipine besylate tablets.

Start Date11 Oct 2024

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

[+1]

CTR20243361 / Active, not recruitingNot Applicable

健康受试者空腹单次口服缬沙坦左氨氯地平片与缬沙坦片（DIOVAN®）和苯磺酸氨氯地平片（络活喜®）的随机、开放、三序列、三周期、部分重复交叉设计的生物等效性试验

[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.

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

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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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