/ CompletedNot Applicable 硫普罗宁片在健康参与者中空腹条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验
[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of tiopronin tablets in healthy participants under fasting conditions
研究空腹状态下单次口服受试制剂(硫普罗宁片,规格0.1g,华益药业科技(安徽)有限公司生产)与参比制剂(硫普罗宁片,规格100mg,商品名:Thiola,ヴィアトリス製薬株式会社生产)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性。
[Translation] To study the pharmacokinetic characteristics of the test preparation (Tiopronin tablets, specification 0.1g, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (Tiopronin tablets, specification 100mg, trade name: Thiola, produced by Viatris Pharmaceutical Co., Ltd.) after a single oral administration in healthy participants under fasting state, compare the bioequivalence of the test preparation and the reference preparation, and study the safety of the drug in healthy participants.
/ CompletedNot Applicable [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.
/ Not yet recruitingNot Applicable 硫普罗宁片在健康参与者中餐后条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验
[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of tiopronin tablets in healthy participants after a mid-day meal
研究餐后状态下单次口服受试制剂(硫普罗宁片,规格0.1g,华益药业科技(安徽)有限公司生产)与参比制剂(硫普罗宁片,规格100mg,商品名:Thiola,ヴィアトリス製薬株式会社生产)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性。
[Translation] To study the pharmacokinetic characteristics of the test preparation (Tiopronin tablets, specification 0.1g, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (Tiopronin tablets, specification 100mg, trade name: Thiola, produced by Viatris Pharmaceutical Co., Ltd.) after a single oral administration in healthy participants in the postprandial state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drugs in healthy participants.
100 Clinical Results associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
100 Deals associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.