[Translation] A single-center, randomized, open-label, two-cycle crossover, single-dose bioequivalence study of Mosapride Citrate Tablets administered in Chinese healthy subjects under fasting conditions; Mosapride Citrate Tablets A single-center, randomized, open-label, four-cycle fully replicated, single-dose postprandial bioequivalence study in healthy Chinese subjects
主要目的:比较空腹及餐后给药条件下,福建省宝诺医药研发有限公司提供的枸橼酸莫沙必利片(规格:5mg)与Sumitomo Pharma Co., Ltd.持证的枸橼酸莫沙必利片(商品名:加斯清®,规格:5mg)在健康人群中吸收程度和速度的差异。
次要目的:评价福建省宝诺医药研发有限公司提供的枸橼酸莫沙必利片(规格:5mg)的安全性。
[Translation] Main purpose: To compare the Mosapride Citrate Tablets (specification: 5mg) provided by Fujian Baonuo Pharmaceutical R&D Co., Ltd. and the certified citrate by Sumitomo Pharma Co., Ltd. under fasting and postprandial administration conditions. Differences in the degree and speed of absorption of Mosapride Tablets (trade name: Gastine®, specification: 5mg) in healthy people.
Secondary purpose: To evaluate the safety of Mosapride Citrate Tablets (specification: 5 mg) provided by Fujian Baonuo Pharmaceutical R&D Co., Ltd.