酮咯酸氨丁三醇片在健康受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验
[Translation] An open, randomized, crossover bioequivalence study of ketorolac tromethamine tablets in healthy subjects under fasting/fed conditions
主要试验目的
研究空腹/餐后状态下单次口服受试制剂酮咯酸氨丁三醇片(规格:10mg,山东朗诺制药有限公司生产)与参比制剂酮咯酸氨丁三醇片(规格:10mg,Granules India Limited生产)在健康受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要试验目的
评估受试制剂酮咯酸氨丁三醇片(规格:10mg)与参比制剂酮咯酸氨丁三醇片(规格:10mg)在健康受试者中的安全性。
[Translation] Main purpose of the study
To study the pharmacokinetics of the test preparation Ketorolac Tromethamine Tablets (Specification: 10 mg, produced by Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation Ketorolac Tromethamine Tablets (Specification: 10 mg, produced by Granules India Limited) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study
To evaluate the safety of the test preparation Ketorolac Tromethamine Tablets (Specification: 10 mg) and the reference preparation Ketorolac Tromethamine Tablets (Specification: 10 mg) in healthy subjects.
非奈利酮片在健康受试者中单中心、开放、随机、单剂量、交叉空腹和餐后状态下的生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study of finerenone tablets in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,山东朗诺制药有限公司生产的非奈利酮片(20mg)与Bayer Healthcare Pharmaceuticals Inc.持证的非奈利酮片(20mg,商品名:KERENDIA)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,山东朗诺制药有限公司生产的非奈利酮片(20mg)与Bayer Healthcare Pharmaceuticals Inc.持证的非奈利酮片(20mg,商品名:KERENDIA)在健康成年人群中的安全性。
[Translation] Primary objective
To compare the differences in the extent and rate of absorption of finerenone tablets (20 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and finerenone tablets (20 mg, trade name: KERENDIA) licensed by Bayer Healthcare Pharmaceuticals Inc. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective
To evaluate the safety of finerenone tablets (20 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. and finerenone tablets (20 mg, trade name: KERENDIA) licensed by Bayer Healthcare Pharmaceuticals Inc. in healthy adults under fasting and postprandial administration conditions.
比拉斯汀口崩片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹状态下的生物等效性试验
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of bilastine orodisintegrating tablets in healthy subjects under fasting conditions
主要目的:比较空腹给药条件下,山东朗诺制药有限公司研制的比拉斯汀口崩片(10mg)与FAES FARMA, S.A.持证的比拉斯汀口崩片(10mg,商品名:Bilaxten)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹给药条件下,山东朗诺制药有限公司研制的比拉斯汀口崩片(10mg)与FAES FARMA, S.A.持证的比拉斯汀口崩片(10mg,商品名:Bilaxten)的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and rate of Bilastine orodisintegrating tablets (10 mg) developed by Shandong Langnuo Pharmaceutical Co., Ltd. and Bilastine orodisintegrating tablets (10 mg, trade name: Bilaxten) licensed by FAES FARMA, S.A. in healthy adults under fasting administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of Bilastine orodisintegrating tablets (10 mg) developed by Shandong Langnuo Pharmaceutical Co., Ltd. and Bilastine orodisintegrating tablets (10 mg, trade name: Bilaxten) licensed by FAES FARMA, S.A. under fasting administration conditions.
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