琥珀酸美托洛尔缓释胶囊(100 mg)健康人体生物等效性研究
[Translation] Bioequivalence study of metoprolol succinate sustained-release capsules (100 mg) in healthy humans
本研究以桂林华信制药有限公司研发的琥珀酸美托洛尔缓释胶囊(规格:100 mg(以酒石酸美托洛尔计))为受试制剂,按生物等效性研究的有关规定,以持证商为Sun Pharmaceutical Industries, Inc.,生产厂家为Ohm Laboratories Inc. 生产的琥珀酸美托洛尔缓释胶囊(规格:100 mg(以酒石酸美托洛尔计),商品名称:Kapspargo Sprinkle®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:观察受试制剂琥珀酸美托洛尔缓释胶囊和参比制剂琥珀酸美托洛尔缓释胶囊(Kapspargo Sprinkle®)在健康受试者中的安全性。
[Translation] This study uses metoprolol succinate sustained-release capsules (specification: 100 mg (based on metoprolol tartrate)) developed by Guilin Huaxin Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations on bioequivalence studies, The licensee is Sun Pharmaceutical Industries, Inc., and the manufacturer is Ohm Laboratories Inc. Metoprolol succinate sustained-release capsules (specification: 100 mg (based on metoprolol tartrate)), trade name: Kapspargo Sprinkle ®) is a reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose: To observe the safety of the test preparation metoprolol succinate extended-release capsules and the reference preparation metoprolol succinate extended-release capsules (Kapspargo Sprinkle®) in healthy subjects.
培哚普利氨氯地平片(III)在空腹及餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence test of perindopril amlodipine tablets (III) under fasting and postprandial conditions
考察空腹及餐后条件下,健康受试者单次口服桂林华信制药有限公司生产的培哚普利氨氯地平片(Ⅲ)【受试制剂T,规格:每片含精氨酸培哚普利10mg和苯磺酸氨氯地平(以氨氯地平计)5mg】或Les Laboratoires Servier 持证的培哚普利氨氯地平片(Ⅲ)【参比制剂R,商品名:开素达®,规格:每片含精氨酸培哚普利10mg 和苯磺酸氨氯地平(以氨氯地平计)5mg】的药动学特征,评价两制剂间的生物等效性和安全性,为受试制剂的注册申请提供依据。
[Translation] Under fasting and postprandial conditions, healthy subjects took a single oral administration of Perindopril Amlodipine Tablets (Ⅲ) produced by Guilin Huaxin Pharmaceutical Co., Ltd. [Test preparation T, specifications: each tablet contains arginine perindol Perindopril 10 mg and amlodipine besylate (calculated as amlodipine) 5 mg] or Les Laboratoires Servier certified perindopril amlodipine tablets (Ⅲ) [reference preparation R, trade name: Kaisuda® , Specifications: Each tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine besylate (calculated as amlodipine). Provide the basis for the registration application of the test preparation.
艾司奥美拉唑镁肠溶胶囊(40 mg)健康人体生物等效性研究
[Translation] Bioequivalence study of esomeprazole magnesium enteric-coated capsules (40 mg) in healthy subjects
主要目的:本研究以桂林华信制药有限公司研制的艾司奥美拉唑镁肠溶胶囊(规格:40mg)为受试制剂,按生物等效性研究的有关规定,以AstraZeneca AB生产的艾司奥美拉唑镁肠溶胶囊(规格:40 mg,商品名:NEXIUM®)为参比制剂,评估受试制剂和参比制剂在空腹/空腹撒拌/餐后条件下给药后的生物等效性。次要目的:观察受试制剂艾司奥美拉唑镁肠溶胶囊和参比制剂艾司奥美拉唑镁肠溶胶囊(商品名:NEXIUM®)在健康受试者中的安全性。
[Translation] Main purpose: In this study, Esomeprazole Magnesium Enteric-Coated Capsules (Specification: 40 mg) developed by Guilin Huaxin Pharmaceutical Co., Ltd. was used as the test preparation. Semeprazole magnesium enteric-coated capsules (specification: 40 mg, trade name: NEXIUM®) were used as the reference preparation, and the biological effects of the test preparation and the reference preparation were evaluated under fasting/fasting mixed/postprandial conditions. equivalence. Secondary purpose: To observe the safety of the test preparation esomeprazole magnesium enteric-coated capsules and the reference preparation esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®) in healthy subjects.
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