/ Not yet recruitingNot Applicable 沙库巴曲缬沙坦钠片(200mg)在中国健康试验参与者中空腹给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully replicated crossover bioequivalence trial of sacubitril/valsartan sodium tablets (200 mg) in healthy Chinese participants under fasting administration conditions.
主要研究目的:按有关生物等效性试验的规定,选择Novartis Pharma Schweiz AG为持证商的沙库巴曲缬沙坦钠片(商品名:诺欣妥®,规格:200mg(沙库巴曲97mg/缬沙坦103mg))为参比制剂,对成都亚中生物制药有限责任公司生产并提供的受试制剂沙库巴曲缬沙坦钠片(规格:200mg(沙库巴曲97mg/缬沙坦103mg))进行空腹给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察健康试验参与者口服受试制剂沙库巴曲缬沙坦钠片(规格:200mg(沙库巴曲97mg/缬沙坦103mg))和参比制剂沙库巴曲缬沙坦钠片(商品名:诺欣妥®,规格:200mg(沙库巴曲97mg/缬沙坦103mg))的安全性。
[Translation] Main research objective: In accordance with relevant bioequivalence testing regulations, sacubitril/valsartan sodium tablets (trade name: Novartis®, specification: 200mg (sacubitril 97mg/valsartan 103mg)) manufactured and supplied by Novartis Pharma Schweiz AG, were selected as the reference formulation. A fasting-administered human bioequivalence study was conducted on the test formulation, sacubitril/valsartan sodium tablets (specification: 200mg (sacubitril 97mg/valsartan 103mg)) manufactured and supplied by Chengdu Yazhong Biopharmaceutical Co., Ltd., to compare whether the differences in the absorption rate and extent of the drug in the test formulation with those in the reference formulation were within acceptable ranges, and to evaluate the bioequivalence of the two formulations under fasting administration conditions.
Secondary study objective: To observe the safety of oral administration of the investigational formulation sacubitril/valsartan sodium tablets (200 mg (sacubitril 97 mg/valsartan 103 mg)) and the reference formulation sacubitril/valsartan sodium tablets (trade name: Nosint®, 200 mg (sacubitril 97 mg/valsartan 103 mg)) in healthy trial participants.
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