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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date12 Dec 2016 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date27 Aug 1999 |
/ CompletedNot Applicable 单中心试验评估健康中国受试者空腹口服单剂量美沙拉秦缓释颗粒和单剂量美沙拉秦缓释片的生物等效性
[Translation] A single-center trial to evaluate the bioequivalence of single-dose mesalazine extended-release granules and single-dose mesalazine extended-release tablets in healthy Chinese subjects after fasting oral administration
主要目的 -证明空腹条件下单剂量 2 g(1 x 2 g)美沙拉秦缓释颗粒与单剂量 2 g(4 x 500 mg)颇得斯安® 片的生物等效性 次要目的 -进一步阐明美沙拉秦缓释颗粒和颇得斯安® 片剂的 PK 特性 ? 评价美沙拉秦缓释颗粒与 颇得斯安® 片剂相比的安全性和耐受性
[Translation] Primary Objective - To demonstrate the bioequivalence of a single dose of 2 g (1 x 2 g) of mesalamine extended-release granules to a single dose of 2 g (4 x 500 mg) of Podesan® tablets under fasting conditions Secondary Objective - To further elucidate the PK properties of mesalamine extended-release granules and Podesan® tablets ? To evaluate the safety and tolerability of mesalamine extended-release granules compared with Podesan® tablets
中国健康受试者中比较去氨加压素冻干物单次舌下含服和弥凝片单次口服的药效学开放、随机、双序列、交叉试验
[Translation] An open, randomized, double-sequence, crossover study comparing the pharmacodynamics of a single sublingual dose of desmopressin lyophilisate and a single oral dose of Mining tablets in healthy Chinese subjects
主要目的
证明去氨加压素口服冻干物单剂量60μg舌下用药与弥凝片0.1mg单剂量0.1mg口服给药后的药效动力学(PD)具有生物等效性(BE)
次要目的
比较去氨加压素口服冻干物单剂量60μg舌下用药与弥凝片0.1mg单剂量0.1mg口服用药的安全性和耐受性
[Translation] Primary objective
To demonstrate that the pharmacodynamics (PD) of a single 60 μg sublingual dose of desmopressin oral lyophilisate is bioequivalent (BE) to that of a single 0.1 mg oral dose of MiNing tablets
Secondary objective
To compare the safety and tolerability of a single 60 μg sublingual dose of desmopressin oral lyophilisate and a single 0.1 mg oral dose of MiNing tablets
中国健康受试者中研究去氨加压素口服冻干物单次舌下含服与弥凝片单次口服的BE开放、随机、双序列、交叉试验
[Translation] An open, randomized, double-sequence, crossover study of the BE of a single sublingual oral lyophilisate of desmopressin versus a single oral dose of Mining tablets in healthy Chinese subjects
主要目的
证明去氨加压素口服冻干物240μg单次舌下给药与弥凝片0.4mg单次口服给药后的药代动力学(AUC和Cmax)具有生物等效性 次要目的
比较去氨加压素口服冻干物240μg单次舌下给药与弥凝片0.4mg单次口服给药的AUCt、% Extrap AUC、Frel、λz、tmax和t?
比较去氨加压素口服冻干物240μg单次舌下给药与弥凝片0.4mg 单次口服给药后的安全性和耐受性
[Translation] Primary objective
To demonstrate that the pharmacokinetics (AUC and Cmax) of desmopressin oral lyophilisate 240 μg are bioequivalent to that of 0.4 mg oral tablets after a single sublingual administration Secondary objective
To compare the AUCt, % Extrap AUC, Frel, λz, tmax and t? of desmopressin oral lyophilisate 240 μg and that of 0.4 mg oral tablets after a single sublingual administration
To compare the safety and tolerability of desmopressin oral lyophilisate 240 μg and that of 0.4 mg oral tablets after a single sublingual administration
100 Clinical Results associated with Huiling Pharmaceutical Consulting (Shanghai) Co., Ltd.
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100 Translational Medicine associated with Huiling Pharmaceutical Consulting (Shanghai) Co., Ltd.