/ CompletedNot Applicable 乌帕替尼缓释片（15mg）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、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of upadacitinib extended-release tablets (15 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AbbVie Deutschland GmbH&Co.KG为持证商的乌帕替尼缓释片（商品名：瑞福®（Rinvoq®），规格：15mg）为参比制剂，对山东诺禾康药业有限公司生产，山东诺明康药物研究院有限公司提供的受试制剂乌帕替尼缓释片（规格：15mg）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，评估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：观察健康志愿受试者口服受试制剂乌帕替尼缓释片（规格：15mg）和参比制剂乌帕替尼缓释片（商品名：瑞福®（Rinvoq®），规格：15mg）的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, upadacitinib extended-release tablets (trade name: Rinvoq®, specification: 15 mg) with AbbVie Deutschland GmbH & Co. KG as the licensee were selected as the reference preparation, and the test preparation upadacitinib extended-release tablets (specification: 15 mg) produced by Shandong Novocon Pharmaceutical Co., Ltd. and provided by Shandong Nomincon Pharmaceutical Research Institute Co., Ltd. were subjected to human bioequivalence test on 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 evaluate 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 upadacitinib extended-release tablets (specification: 15 mg) and the reference preparation upadacitinib extended-release tablets (trade name: Rinvoq®, specification: 15 mg) by healthy volunteers.
/ CompletedNot Applicable 达格列净片（10mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) in healthy Chinese subjects under fasting conditions
主要研究目的：按有关生物等效性试验的规定，选择AstraZeneca AB为持证商的达格列净片（商品名：安达唐（FORXIGA），规格：10mg）为参比制剂，对济南高华制药有限公司生产、山东诺明康药物研究院有限公司持证的受试制剂达格列净片（规格：10mg）进行空腹给药条件下的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，评价两种制剂在空腹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达格列净片（规格：10mg）和参比制剂达格列净片（商品名：安达唐（FORXIGA），规格：10mg）的安全性。
[Translation] Main purpose of study: According to the provisions of relevant bioequivalence test, dapagliflozin tablets (trade name: FORXIGA, specification: 10mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10mg) produced by Jinan Gaohua Pharmaceutical Co., Ltd. and licensed by Shandong Nuo Mingkang Pharmaceutical Research Institute Co., Ltd. were tested in human body under fasting conditions, 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 evaluate the bioequivalence of the two preparations under fasting conditions.
Secondary purpose of study: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA, specification: 10mg) by healthy subjects.
/ CompletedNot Applicable 达格列净片（10mg）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、两序列、两周期、双交叉生物等效性试验。
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) in healthy Chinese subjects under fasting and fed dosing conditions.
主要研究目的：按有关生物等效性试验的规定，选择AstraZeneca AB为持证商的达格列净片（商品名：安达唐（FORXIGA），规格：10mg）为参比制剂，对山东诺明康药物研究院有限公司提供的受试制剂达格列净片（规格：10mg）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，评估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：观察健康志愿受试者口服受试制剂达格列净片（规格：10mg）和参比制剂达格列净片（商品名：安达唐（FORXIGA），规格：10mg）的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10 mg) provided by Shandong Nuo Mingkang Pharmaceutical Research Institute Co., Ltd. were subjected to human bioequivalence test on 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 evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) by healthy volunteers.
100 Clinical Results associated with Shandong Nuomingkang Pharmaceutical Research Institute Co., Ltd.
0 Patents (Medical) associated with Shandong Nuomingkang Pharmaceutical Research Institute Co., Ltd.
100 Deals associated with Shandong Nuomingkang Pharmaceutical Research Institute Co., Ltd.
100 Translational Medicine associated with Shandong Nuomingkang Pharmaceutical Research Institute Co., Ltd.
