[Translation] Bioequivalence study of guaiacol glycerin double-layer sustained-release tablets in humans
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] Using a single-center, randomized, open, two-period crossover, single oral trial design to compare fasting and postprandial administration conditions, the guaiacol glycerin double-layer sustained-release tablets provided by Beijing Boya United Pharmaceutical Institute Co., Ltd. ( 600 mg) and guaiacol glycerin ether bilayer sustained-release tablets (600 mg, trade name: Mucinex®) produced by RB HEALTH US LLC in the absorption degree and absorption speed of healthy Chinese people, and to evaluate the combination of Beijing Boya drug Safety of Guaifenesin Bilayer Sustained Release Tablets Provided by Institute Ltd.
[Translation] Human Bioequivalence Test of Pravastatin Sodium Tablets
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] Using a single-center, randomized, open, three-cycle, partially repeated crossover, single-dose administration design to compare fasting and postprandial administration conditions, pravastatin sodium tablets (specification: 40 mg) and pravastatin sodium tablets (trade name: Prareduct®; specification: 40 mg) produced under license by Daiichi Sankyo Belgium S.A. The safety of pravastatin sodium tablets (specification: 40 mg) provided by China Pharmaceutical Co., Ltd.
[Translation] Human Bioequivalence Study of Compound Glycyrrhizin Capsules
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] The compound glycyrrhizin capsules provided by Beijing Boya Institute of Medicine Co., Ltd. (specification: each capsule contains glycyrrhizin 25mg, glycine 25mg, DL-methionine 25mg) are the test preparations and compound glycyrrhizin tablets licensed by Minophagen Pharmaceutical Co., Ltd. (specification: each tablet contains glycyrrhizin 25mg, glycine 25mg, DL-methionine 25mg; commodity Name: Meineng®/Stronger Neo-Minophagen C®) is the bioequivalence of the reference preparation in healthy people on an empty stomach and after a meal. Provide evidence for the consistency of clinical efficacy of compound glycyrrhizin tablets licensed by Co., Ltd.
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