[Translation] An open-label, randomized, two-stage, single-dose, two-cycle, two-crossover, bioequivalence study comparing fluticasone propionate aerosol inhalation suspension and a reference preparation in fasting Chinese healthy subjects
主要研究目的 中国健康受试者在空腹状态下,评价单次吸入1 mg丙酸氟替卡松雾化吸入用混悬液与1 mg参比试剂的药代动力学(PK)特征,评价两种制剂的生物等效性。 次要研究目的 中国健康受试者在空腹状态下,单次吸入1 mg丙酸氟替卡松雾化吸入用混悬液与1 mg参比试剂,评价两种制剂的安全性和耐受性。
[Translation] Main study objective To evaluate the pharmacokinetic (PK) characteristics of a single inhalation of 1 mg fluticasone propionate aerosol inhalation suspension and 1 mg reference reagent in healthy Chinese subjects in a fasting state, and to evaluate the pharmacokinetics (PK) characteristics of the two preparations. Bioequivalence. Secondary study objectives To evaluate the safety and tolerability of the two preparations by single inhalation of 1 mg of fluticasone propionate aerosol inhalation suspension and 1 mg of reference reagent in healthy Chinese subjects in a fasting state.