[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of olanzapine orodisintegrating tablets 5 mg in healthy volunteers under postprandial conditions
主要研究目的 比较北京金康驰医药投资有限公司进口的奥氮平口崩片(规格:5mg/片,受试制剂)与持证商Eli Lilly Nederland B.V.的奥氮平口崩片(规格:5mg/片,商品名:Zyprexa,参比制剂)在健康受试者体内的药代动力学,评价餐后状态下口服两种制剂的生物等效性。 次要研究目的 观察受试制剂奥氮平口崩片5mg和参比制剂Zyprexa 5mg在健康受试者中的安全性。
[Translation] The main purpose of the study was to compare the pharmacokinetics of olanzapine orodisintegrating tablets (specification: 5 mg/tablet, test preparation) imported by Beijing Jinkangchi Pharmaceutical Investment Co., Ltd. and olanzapine orodisintegrating tablets (specification: 5 mg/tablet, trade name: Zyprexa, reference preparation) from the licensed manufacturer Eli Lilly Nederland B.V. in healthy subjects, and to evaluate the bioequivalence of the two preparations taken orally in the fed state. The secondary purpose of the study was to observe the safety of the test preparation olanzapine orodisintegrating tablets 5 mg and the reference preparation Zyprexa 5 mg in healthy subjects.