[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of levamlodipine besylate tablets in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,福安药业集团宁波天衡制药有限公司提供的苯磺酸左氨氯地平片(5mg(按C20H25CIN2O5计))与辉瑞制药有限公司持证的苯磺酸氨氯地平片(10mg,商品名:络活喜(Norvasc))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,福安药业集团宁波天衡制药有限公司提供的苯磺酸左氨氯地平片(5mg(按C20H25CIN2O5计))与辉瑞制药有限公司持证的苯磺酸氨氯地平片(10mg,商品名:络活喜(Norvasc))在健康成年人群中的安全性。
[Translation] Main purpose
To compare the differences in absorption extent and rate of levamlodipine besylate tablets (5 mg (calculated as C20H25CIN2O5)) provided by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group and amlodipine besylate tablets (10 mg, trade name: Norvasc) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of levamlodipine besylate tablets (5 mg (calculated as C20H25CIN2O5)) provided by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group and amlodipine besylate tablets (10 mg, trade name: Norvasc) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy adults under fasting and postprandial administration conditions.