[Translation] A randomized, open-label, two-period, two-sequence, two-crossover bioequivalence study of olopatadine hydrochloride tablets 5 mg in healthy volunteers under fasting and fed conditions
健康受试者空腹、餐后口服单剂量盐酸奥洛他定片(受试制剂,河北创健药业有限公司研制)与原研药—盐酸奥洛他定片(商品名:阿洛刻;参比制剂,协和发酵麒麟株式会社富士工厂(Kyowa Hakko Kirin Co.,Ltd.Fuji Plant)生产)后,测定血浆中奥洛他定的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
[Translation] After healthy subjects took a single dose of olopatadine hydrochloride tablets (test preparation, developed by Hebei Chuangjian Pharmaceutical Co., Ltd.) and the original drug, olopatadine hydrochloride tablets (trade name: Aloka; reference preparation, produced by Kyowa Hakko Kirin Co., Ltd. Fuji Plant) orally on an empty stomach or after a meal, the concentration of olopatadine in plasma was measured, the absorption rate and extent of the test preparation and the reference preparation were studied, and whether the test preparation and the reference preparation were bioequivalent was evaluated.