[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of anagrelide hydrochloride capsules in healthy Chinese adult subjects under fasting/fed conditions
考察中国成年健康受试者空腹/餐后单次口服受试制剂盐酸阿那格雷胶囊的人体药代动力学特征,并与已上市的盐酸阿那格雷胶囊为参比制剂,两周期、两交叉设计进行人体生物等效性研究,并观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The pharmacokinetic characteristics of the test preparation anagrelide hydrochloride capsules were investigated after a single oral administration on an empty stomach or after a meal in healthy adult Chinese subjects. A two-period, two-crossover design was used to conduct a human bioequivalence study using the marketed anagrelide hydrochloride capsules as the reference preparation, and the safety of the test preparation and the reference preparation in healthy subjects was observed.