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布地奈德福莫特罗吸入粉雾剂(II)在健康人体的生物等效性预试验
[Translation] Preliminary bioequivalence test of budesonide and formoterol inhalation powder (II) in healthy subjects
在空腹吸入给药条件下,以药代动力学参数为终点指标,评估上海新黄河制药有限公司生产的布地奈德福莫特罗吸入粉雾剂(II)(规格:160μg/4.5μg)与AstraZeneca AB生产的布地奈德福莫特罗吸入粉雾剂(II)(信必可®都保®,规格:160μg/4.5μg)在人体内的药代动力学特征,考察给药方式与操作流程、采样量、采血时间、时间间隔等设置的合理性及检测方法的可行性,为正式试验提供参考依据。
[Translation] Under the condition of inhalation administration on an empty stomach, taking pharmacokinetic parameters as the endpoint indicators, the budesonide formoterol inhalation powder (II) (specification: 160μg/4.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. Pharmacokinetic characteristics of budesonide and formoterol inhalation powder (II) produced by AstraZeneca AB (Sympec® Dubo®, specification: 160μg/4.5μg) in human body, investigating the mode of administration and operation The rationality of the process, sampling volume, blood collection time, time interval and other settings and the feasibility of the detection method provide a reference for the formal test.
布地奈德福莫特罗吸入粉雾剂(II)在健康人体的生物等效性预试验
[Translation] Preliminary bioequivalence test of budesonide and formoterol inhalation powder (II) in healthy subjects
在空腹吸入给药条件下,以药代动力学参数为终点指标,评估上海新黄河制药有限公司生产的布地奈德福莫特罗吸入粉雾剂(II)(规格:160μg/4.5μg)与AstraZeneca AB生产的布地奈德福莫特罗吸入粉雾剂(II)(信必可®都保®,规格:160μg/4.5μg)在人体内的药代动力学特征,考察给药方式与操作流程、采样量、采血时间、时间间隔等设置的合理性及检测方法的可行性,为正式试验提供参考依据。
[Translation] Under the condition of inhalation administration on an empty stomach, taking pharmacokinetic parameters as the endpoint indicators, the budesonide formoterol inhalation powder (II) (specification: 160μg/4.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. Pharmacokinetic characteristics of budesonide and formoterol inhalation powder (II) produced by AstraZeneca AB (Sympec® Dubo®, specification: 160μg/4.5μg) in human body, investigating the mode of administration and operation The rationality of the process, sampling volume, blood collection time, time interval and other settings and the feasibility of the detection method provide a reference for the formal test.
丙酸氟替卡松雾化吸入用混悬液在健康人体的生物等效性试验
[Translation] Bioequivalence test of fluticasone propionate aerosol inhalation suspension in healthy subjects
在空腹雾化吸入给药条件下,以药代动力学参数为终点指标,评估上海新黄河制药有限公司生产的丙酸氟替卡松雾化吸入用混悬液(规格:2ml:0.5mg)与GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液(辅舒酮Flixotide Nebules®,规格:2ml:0.5mg)在人体内的药代动力学特征,评价受试制剂和参比制剂的生物等效性和安全性。
[Translation] Under the condition of fasting nebulization inhalation administration, with pharmacokinetic parameters as endpoint indicators, the fluticasone propionate nebulized inhalation suspension (specification: 2ml:0.5mg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. was evaluated with GlaxoSmithKline Australia Pharmacokinetic characteristics of fluticasone propionate nebulized inhalation suspension (Flixotide Nebules®, specification: 2ml:0.5mg) produced by Pty Ltd. in humans, to evaluate the biological properties of test preparations and reference preparations Equivalence and Safety.
100 Clinical Results associated with Shanghai New Yellow River Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai New Yellow River Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai New Yellow River Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai New Yellow River Pharmaceutical Co., Ltd.