/ CompletedNot Applicable [Translation] Bioequivalence study of butylphthalide soft capsules in humans under fasting conditions
考察健康受试者在空腹条件下，单次口服1粒由安徽艾立德制药有限公司提供的丁苯酞软胶囊（受试制剂，规格：0.1g）与单次口服1粒由石药集团恩必普药业有限公司生产的丁苯酞软胶囊（参比制剂，商品名：恩必普®，规格：0.1g）的药代动力学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of healthy subjects under fasting conditions, when taking a single oral dose of 1 tablet of butylphthalide soft capsule (test preparation, specification: 0.1g) provided by Anhui Ailede Pharmaceutical Co., Ltd. and a single oral dose of 1 tablet of butylphthalide soft capsule (reference preparation, trade name: Enbipu®, specification: 0.1g) produced by CSPC Pharmaceutical Group Enbipu Pharmaceutical Co., Ltd., and evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable [Translation] Bioequivalence study of iguratimod tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下，单次口服由安徽艾立德制药有限公司提供的艾拉莫德片（受试制剂，规格：25mg）与相同条件下单次口服由海南先声药业有限公司持证的艾拉莫德片（参比制剂，商品名：艾得辛®，规格：25mg）的药动学特征，评价两制剂间的生物等效性及安全性，为该受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of Iguratimod tablets (test preparation, specification: 25 mg) provided by Anhui Ailede Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of Iguratimod tablets (reference preparation, trade name: Edexin®, specification: 25 mg) certified by Hainan Xiansheng Pharmaceutical Co., Ltd. under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable 盐酸决奈达隆片（400mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, crossover bioequivalence study of dronedarone hydrochloride tablets (400 mg) in healthy Chinese subjects under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择Sanofi Aventis U.S., LLC为持证商的盐酸决奈达隆片（商品名：迈达龙®，规格：400mg）为参比制剂，对安徽艾立德制药有限公司生产、江苏艾立康医药科技有限公司提供的受试制剂盐酸决奈达隆片（规格：400mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康受试者口服受试制剂盐酸决奈达隆片（规格：400mg）和参比制剂盐酸决奈达隆片（商品名：迈达龙®，规格：400mg）的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) of which Sanofi Aventis U.S., LLC is the licensee was selected as the reference preparation, and the test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Anhui Aili Pharmaceutical Co., Ltd. and provided by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation dronedarone hydrochloride tablets (specification: 400mg) and the reference preparation dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) in healthy subjects.
100 Clinical Results associated with Anhui Ailide Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Anhui Ailide Pharmaceutical Co., Ltd.
100 Deals associated with Anhui Ailide Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Anhui Ailide Pharmaceutical Co., Ltd.
