[Translation] Bioequivalence study of valsartan and amlodipine tablets (II) in single center, randomized, open, single dose, two preparations, three sequences, three cycles, partially repeated crossover fasting and fed states in healthy subjects
主要目的
比较空腹和餐后给药条件下,浙江众延医药科技有限公司提供的缬沙坦氨氯地平片(II)(规格:每片含缬沙坦160mg,氨氯地平5mg)与Novartis Pharmaceuticals Corporation持证的缬沙坦氨氯地平片(II)(规格:缬沙坦/氨氯地平 mg:160/5;商品名:Exforge®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,浙江众延医药科技有限公司提供的缬沙坦氨氯地平片(II)(规格:每片含缬沙坦160mg,氨氯地平5mg)与Novartis Pharmaceuticals Corporation持证的缬沙坦氨氯地平片(II)(规格:缬沙坦/氨氯地平 mg:160/5;商品名:Exforge®)的安全性。
[Translation] main purpose
Compared with fasting and postprandial administration conditions, the valsartan and amlodipine tablets (II) provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. (specifications: each tablet contains 160 mg valsartan and 5 mg amlodipine) are on par with Novartis Pharmaceuticals Corporation. valsartan and amlodipine tablets (II) (specification: valsartan/amlodipine mg: 160/5; trade name: Exforge®) in the healthy adult population, the difference in the absorption degree and speed, evaluation of its biological Effectiveness.
secondary purpose
Valsartan and Amlodipine Tablets (II) provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd. (specification: each tablet contains 160 mg of valsartan and 5 mg of amlodipine) are in agreement with Novartis Pharmaceuticals Corporation to evaluate the conditions of fasting and postprandial administration. The safety of valsartan and amlodipine tablets (II) (specification: valsartan/amlodipine mg: 160/5; trade name: Exforge®) certified by