[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover pharmacokinetic comparison trial of fluticasone propionate cream in healthy study participants under fasting conditions.
主要目的:旨在研究单次空腹涂抹使用山东辰欣佛都药业股份有限公司持证的丙酸氟替卡松乳膏(0.05%(15 g))的药代动力学特征;以GlaxoSmithKline (Ireland) Limited持证的丙酸氟替卡松乳膏(Cutivate®,0.05%(15 g))为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,研究局部给药后受试制剂与参比制剂的体内暴露量差异。
次要目的:评价受试制剂和参比制剂在中国成年健康研究参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of fluticasone propionate cream (0.05% (15 g)) certified by Shandong Chenxin Fodu Pharmaceutical Co., Ltd., applied topically on an empty stomach; using fluticasone propionate cream (Cutivate®, 0.05% (15 g)) certified by GlaxoSmithKline (Ireland) Limited as the reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to study the difference in in vivo exposure between the test and reference formulations after topical administration.
Secondary objective: To evaluate the safety of the test and reference formulations in Chinese adult healthy study participants.