/ Not yet recruitingNot Applicable 硫酸沙丁胺醇吸入气雾剂在健康试验参与者中空腹状态下的随机、开放、单剂量、两周期、两序列、交叉生物等效性预试验
[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence pre-trial of salbutamol sulfate inhalation aerosol in healthy participants under fasting conditions.
主要研究目的:本试验以江苏德迈药业有限公司生产的硫酸沙丁胺醇吸入气雾剂为受试制剂,原研Glaxo Wellcome S.A.公司生产的硫酸沙丁胺醇吸入气雾剂(商品名:Ventolin® HFA/万托林®)为参比制剂,考察受试制剂和参比制剂在健康试验参与者中空腹条件下的药代动力学特征,为正式试验的采血时间点及所需试验参与者例数等设计提供依据。
次要研究目的:观察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] Primary objective: This study uses salbutamol sulfate inhalation aerosol manufactured by Jiangsu Demai Pharmaceutical Co., Ltd. as the test formulation and salbutamol sulfate inhalation aerosol manufactured by Glaxo Wellcome S.A. (trade name: Ventolin® HFA) as the reference formulation. The pharmacokinetic characteristics of the test and reference formulations under fasting conditions in healthy participants will be investigated to provide a basis for the design of blood collection time points and the required number of participants in the formal trial.
Secondary objective: To observe the safety of the test and reference formulations in healthy participants.
100 Clinical Results associated with Jiangsu Demai Pharmaceutical Co., Ltd.
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