[Translation] An open, randomized, two-stage, single-dose, two-period, two-crossover, bioequivalence study comparing fluticasone propionate nebulized inhalation suspension and reference product in Chinese healthy subjects in the fasting state
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] Primary study objective: To evaluate the pharmacokinetic (PK) characteristics of a single inhalation of 1 mg fluticasone propionate suspension for nebulized inhalation and 1 mg reference reagent in healthy Chinese subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary study objective: To evaluate the safety and tolerability of a single inhalation of 1 mg fluticasone propionate suspension for nebulized inhalation and 1 mg reference reagent in healthy Chinese subjects under fasting conditions.