[Translation] Study on the bioequivalence of compound glycyrrhizic acid tablets in healthy volunteers
采用单中心、随机、开放、四周期完全重复交叉设计、单剂量设计比较空腹和餐后给药条件下,北京远方通达医药技术有限公司提供的复方甘草酸苷片(规格:每片含甘草酸单铵盐35 mg(甘草酸苷25 mg)、甘氨酸25 mg、DL-蛋氨酸25 mg)与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片(规格:每片含甘草酸单铵盐35 mg(甘草酸苷25 mg)、甘氨酸25 mg、DL-蛋氨酸25 mg;商品名:美能®/Stronger Neo-Minophagen C®)在健康人群中吸收程度和速度的差异,并评价北京远方通达医药技术有限公司提供的复方甘草酸苷片与与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片的安全性和耐受性
[Translation] A single-center, randomized, open-label, four-period completely repeated crossover design and single-dose design were used to compare the differences in absorption extent and rate between the compound glycyrrhizic acid tablets (specifications: each tablet contains 35 mg monoammonium glycyrrhizic acid (25 mg glycyrrhizic acid), 25 mg glycine, and 25 mg DL-methionine) provided by Beijing Yuanfangtongda Pharmaceutical Technology Co., Ltd. and the compound glycyrrhizic acid tablets (specifications: each tablet contains 35 mg monoammonium glycyrrhizic acid (25 mg glycyrrhizic acid), 25 mg glycine, and 25 mg DL-methionine; trade name: Minophagen®/Stronger Neo-Minophagen C®) certified by Minophagen Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions in healthy people, and to evaluate the safety and tolerability of the compound glycyrrhizic acid tablets provided by Beijing Yuanfangtongda Pharmaceutical Technology Co., Ltd. and the compound glycyrrhizic acid tablets certified by Minophagen Pharmaceutical Co., Ltd.
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