[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, double-crossover bioequivalence study of granisetron transdermal patch in Chinese healthy volunteers under topical conditions
主要目的:以格拉司琼的主要药代动力学参数(AUC和Cmax)为生物等效性的评价指标,在中国健康受试者外用条件下评估受试制剂(杭州朱养心药业有限公司生产的格拉司琼透皮贴片,规格34.3mg/52cm2)和参比制剂(Kyowa Kirin Inc.持证的格拉司琼透皮贴片,规格34.3mg/52cm2,商品名:善可舒®)的生物等效性。
次要目的:观察外用条件下受试制剂和参比制剂的黏附性、刺激性和安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test preparation (granisetron transdermal patch produced by Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., specification 34.3mg/52cm2) and the reference preparation (granisetron transdermal patch certified by Kyowa Kirin Inc., specification 34.3mg/52cm2, trade name: Sancuso®) under topical conditions in Chinese healthy subjects using the main pharmacokinetic parameters (AUC and Cmax) of granisetron as bioequivalence evaluation indicators.
Secondary objective: To observe the adhesion, irritation and safety of the test preparation and the reference preparation under topical conditions.