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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Human Bioequivalence Study of Fluticasone Propionate Inhalation Suspension
主要研究目的:比较受试制剂和参比制剂在健康受试者体内的药代动力学,评价两者空腹单次吸入给药的生物等效性
次要研究目的:考察受试制剂和参比制剂在健康受试者中的安全性
[Translation] Main research purpose: To compare the pharmacokinetics of the test preparation and the reference preparation in healthy subjects, and to evaluate the bioequivalence of the two in a single fasting inhalation administration
Secondary research purpose: To investigate the safety of test and reference products in healthy subjects
[Translation] Pharmacokinetic study of levalbuterol hydrochloride ipratropium inhalation solution in humans
主要研究目的:测定受试制剂及对照药物在健康受试者空腹条件下的药代动力学参数,考察采血、给药剂量等设置的合理性,验证血药浓度分析方法,筛选合适的雾化装置。
次要研究目的:考察受试制剂和对照药物在健康受试者中的安全性。
[Translation] Main research purposes: To determine the pharmacokinetic parameters of test preparations and reference drugs under fasting conditions in healthy subjects, to investigate the rationality of blood collection and dosage settings, to verify the analysis method of blood drug concentration, and to screen suitable nebulizers. device.
Secondary research objectives: To investigate the safety of test preparations and control drugs in healthy subjects.
[Translation] Human Bioequivalence Study of Fluticasone Propionate Inhalation Suspension
预试验目的:
研究受试制剂和参比制剂在健康受试者空腹条件下的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;验证血液中药物浓度分析方法;考察两制剂在受试者中的安全性。
正式试验目的:
比较受试制剂和参比制剂在健康受试者体内的药代动力学,评价两者空腹单次吸入给药的生物等效性;考察两制剂在受试者中的安全性。
[Translation] Pre-test purpose:
To study the administration method and operation process of the test preparation and reference preparation under fasting conditions in healthy subjects, the rationality of sampling volume, blood collection time, time interval, etc.; to verify the analysis method of drug concentration in blood; Safety in Subjects.
Formal test purpose:
The pharmacokinetics of the test preparation and the reference preparation in healthy subjects were compared, and the bioequivalence of the two preparations in a single fasting inhalation was evaluated; the safety of the two preparations in the subjects was investigated.
100 Clinical Results associated with Shanghai Fangyu Health Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Shanghai Fangyu Health Pharmaceutical Technology Co., Ltd.
100 Deals associated with Shanghai Fangyu Health Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Shanghai Fangyu Health Pharmaceutical Technology Co., Ltd.