[Translation] A single-center, randomized, open-label, single-dose, two-sequence, four-period crossover clinical trial to evaluate the relative bioavailability of amuletine hydrochloride enteric-coated tablets in healthy subjects
主要目的:评价健康受试者空腹和餐后单次口服盐酸阿姆西汀肠溶片不同制剂的相对生物利用度
次要目的:1.在健康受试者中评价空腹和餐后单次口服盐酸阿姆西汀肠溶片新制剂和原制剂后的安全性和耐受性;2.评价健康受试者单次口服盐酸阿姆西汀肠溶片新制剂和原制剂的食物影响
[Translation] Primary objective: To evaluate the relative bioavailability of different formulations of enteric-coated tablets of Amuocetine hydrochloride in healthy subjects after a single oral administration on an empty stomach or after a meal
Secondary objectives: 1. To evaluate the safety and tolerability of the new and original formulations of enteric-coated tablets of Amuocetine hydrochloride in healthy subjects after a single oral administration on an empty stomach or after a meal; 2. To evaluate the food effects of the new and original formulations of enteric-coated tablets of Amuocetine hydrochloride in healthy subjects after a single oral administration