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MechanismTubulin inhibitors |
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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ RecruitingNot Applicable [Translation] Bioequivalence study of orlistat capsules
主要目的:以湖南迪诺制药股份有限公司的奥利司他胶囊(规格:60mg)为受试制剂,以GlaxoSmithKline Consumer Healthcare的奥利司他胶囊(规格:60mg,商品名:Alli®)为参比制剂。考察两种奥利司他胶囊的药效学差异。评价两制剂生物等效性。
次要目的:观察多次服用奥利司他胶囊在健康研究参与者中的安全性。
[Translation] Primary objective: Orlistat capsules (specification: 60 mg) of Hunan Dino Pharmaceutical Co., Ltd. were used as the test preparation, and orlistat capsules (specification: 60 mg, trade name: Alli®) of GlaxoSmithKline Consumer Healthcare were used as the reference preparation. The pharmacodynamic differences between the two orlistat capsules were investigated. The bioequivalence of the two preparations was evaluated.
Secondary objective: To observe the safety of repeated use of orlistat capsules in healthy study participants.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of vonoprazan fumarate tablets in healthy volunteers
旨在研究单次餐后口服湖南迪诺制药股份有限公司研制、生产的富马酸伏诺拉生片(20mg)的药代动力学特征;以Takeda Pharmaceutical Company Limited 生产的富马酸伏诺拉生片(沃克®,20mg)为参比制剂,比较两制剂中药代动力学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性
[Translation] To investigate the pharmacokinetic characteristics of vonoprazan fumarate tablets (20 mg) developed and produced by Hunan Dino Pharmaceutical Co., Ltd. after a single oral administration after a meal; to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations with vonoprazan fumarate tablets (Walker®, 20 mg) produced by Takeda Pharmaceutical Company Limited as the reference preparation, and to evaluate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of vonoprazan fumarate tablets in healthy volunteers
旨在研究单次空腹口服湖南迪诺制药股份有限公司研制、生产的富马酸伏诺拉生片(20mg)的药代动力学特征;以Takeda Pharmaceutical Company Limited 生产的富马酸伏诺拉生片(沃克®,20mg)为参比制剂,比较两制剂中药代动力学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The aim was to study the pharmacokinetic characteristics of a single fasting oral dose of vonoprazan fumarate tablets (20 mg) developed and produced by Hunan Dino Pharmaceutical Co., Ltd.; using vonoprazan fumarate tablets (Walker®, 20 mg) produced by Takeda Pharmaceutical Company Limited as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Hunan Dinuo Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Hunan Dinuo Pharmaceutical Co. Ltd.
100 Deals associated with Hunan Dinuo Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Hunan Dinuo Pharmaceutical Co. Ltd.