Target- |
Mechanism- |
|
|
Active Indication- |
Inactive Indication- |
Drug Highest PhaseIND Application |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Study on the bioequivalence of guaifenesin bilayer sustained-release tablets in healthy volunteers
采用单中心、随机、开放、双周期交叉、单次口服试验设计比较空腹和餐后给药条件下,北京柏雅联合药物研究所有限公司提供的愈创木酚甘油醚双层缓释片(600 mg)与RB HEALTH US LLC生产的愈创木酚甘油醚双层缓释片(600 mg,商品名:Mucinex®)在中国健康人群吸收程度和吸收速度的差异,并评价北京柏雅联合药物研究所有限公司提供的愈创木酚甘油醚双层缓释片的安全性。
[Translation] A single-center, randomized, open, two-period crossover, single oral trial design was used to compare the differences in absorption extent and rate of guaifenesin bilayer sustained-release tablets (600 mg) provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. and guaifenesin bilayer sustained-release tablets (600 mg, trade name: Mucinex®) produced by RB HEALTH US LLC in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of guaifenesin bilayer sustained-release tablets provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd.
[Translation] Bioequivalence study of pravastatin sodium tablets in human body
采用单中心、随机、开放、三周期、部分重复交叉、单剂量给药设计比较空腹和餐后给药条件下,北京柏雅联合药物研究所有限公司提供的普伐他汀钠片(规格:40 mg)与Daiichi Sankyo Belgium S.A.持证生产的普伐他汀钠片(商品名:Prareduct®;规格:40 mg)在中国健康人群中吸收程度和吸收速度的差异,并评价北京柏雅联合药物研究所有限公司提供的普伐他汀钠片(规格:40 mg)的安全性。
[Translation] A single-center, randomized, open, three-period, partially repeated crossover, single-dose design was used to compare the differences in absorption extent and rate of pravastatin sodium tablets (specification: 40 mg) provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. and pravastatin sodium tablets (trade name: Prareduct®; specification: 40 mg) produced by Daiichi Sankyo Belgium S.A. under fasting and postprandial administration in healthy Chinese people, and to evaluate the safety of pravastatin sodium tablets (specification: 40 mg) provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd.
[Translation] Study on the bioequivalence of compound glycyrrhizic acid capsules in healthy volunteers
采用单中心、随机、开放、三周期部分重复交叉、单剂量、空腹和餐后给药设计评价北京柏雅联合药物研究所有限公司提供的复方甘草酸苷胶囊(规格:每粒含甘草酸苷25mg、甘氨酸25mg、DL-蛋氨酸25mg)为受试制剂和Minophagen Pharmaceutical Co.,Ltd.持证的复方甘草酸苷片(规格:每片含甘草酸苷25mg、甘氨酸25mg、DL-蛋氨酸25mg;商品名:美能®/Stronger Neo-Minophagen C®)为参比制剂在健康人群空腹、餐后口服的生物等效性,为北京柏雅联合药物研究所有限公司提供的复方甘草酸苷胶囊与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片临床疗效的一致性提供证据。
[Translation] A single-center, randomized, open, three-period partially repeated crossover, single-dose, fasting and postprandial administration design was used to evaluate the bioequivalence of compound glycyrrhizin capsules (specifications: each capsule contains 25 mg glycyrrhizin, 25 mg glycine, and 25 mg DL-methionine) provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. as the test preparation and compound glycyrrhizin tablets (specifications: each tablet contains 25 mg glycyrrhizin, 25 mg glycine, and 25 mg DL-methionine; trade name: Stronger Neo-Minophagen C®) certified by Minophagen Pharmaceutical Co., Ltd. as the reference preparation in healthy people when taken orally on an empty stomach and after a meal, to provide evidence for the consistency of clinical efficacy between compound glycyrrhizin capsules provided by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. and compound glycyrrhizin tablets certified by Minophagen Pharmaceutical Co., Ltd.
100 Clinical Results associated with Beijing Baiya United Medicine Research Institute Co.,Ltd.
0 Patents (Medical) associated with Beijing Baiya United Medicine Research Institute Co.,Ltd.
100 Deals associated with Beijing Baiya United Medicine Research Institute Co.,Ltd.
100 Translational Medicine associated with Beijing Baiya United Medicine Research Institute Co.,Ltd.