/ Not yet recruitingNot Applicable 复方甘草酸苷片在健康受试者中空腹状态下的单剂量、随机、开放、四周期、两序列、完全重复交叉设计的生物等效性试验
[Translation] A single-dose, randomized, open-label, four-period, two-sequence, completely repeated crossover bioequivalence study of compound glycyrrhizin tablets in healthy subjects under fasting condition
主要研究目的
研究空腹状态下单次口服受试制剂复方甘草酸苷片（规格：甘草酸单铵盐 35mg（甘草酸苷25mg）、甘氨酸 25mg、DL-蛋氨酸 25mg，深圳信立泰药业股份有限公司生产，广东粤和泽药物研究有限公司持证）与参比制剂复方甘草酸苷片（商品名：美能®，规格：甘草酸单铵盐 35mg（甘草酸苷 25mg）、甘氨酸 25mg、DL-蛋氨酸25mg，Akiyama Jozai Co., Ltd. Head Factory 生产，Minophagen Pharmaceutical Co., Ltd.持证）在健康成年受试者体内的药代动力学，评价空腹口服两种制剂的生物等效性。
次要研究目的
评价健康受试者空腹单次口服受试制剂（T）复方甘草酸苷片和参比制剂（R）复方甘草酸苷片（美能®）后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation compound glycyrrhizin tablets (specifications: glycyrrhizic acid monoammonium salt 35mg (glycyrrhizic acid 25mg), glycine 25mg, DL-methionine 25mg, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd., licensed by Guangdong Yueheze Pharmaceutical Research Co., Ltd.) and the reference preparation compound glycyrrhizin tablets (trade name: Mei Neng®, specifications: glycyrrhizic acid monoammonium salt 35mg (glycyrrhizic acid 25mg), glycine 25mg, DL-methionine 25mg, produced by Akiyama Jozai Co., Ltd. Head Factory, licensed by Minophagen Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations after fasting oral administration.
Secondary study objectives
To evaluate the safety of the test preparation (T) compound glycyrrhizin tablets and the reference preparation (R) compound glycyrrhizin tablets (Meineng®) after a single oral administration under fasting conditions in healthy subjects.
/ Not yet recruitingNot Applicable 复方甘草酸苷片在健康受试者中餐后状态下的单剂量、随机、开放、三周期、三序列、部分重复交叉设计的生物等效性试验
[Translation] A single-dose, randomized, open-label, three-period, three-sequence, partially repeated crossover bioequivalence study of compound glycyrrhizic acid tablets in healthy volunteers in the postprandial state
主要研究目的
研究餐后状态下单次口服受试制剂复方甘草酸苷片（规格：甘草酸单铵盐 35mg（甘草酸苷25mg）、甘氨酸 25mg、DL-蛋氨酸 25mg，深圳信立泰药业股份有限公司生产，广东粤和泽药物研究有限公司持证）与参比制剂复方甘草酸苷片（商品名：美能®，规格：甘草酸单铵盐 35mg（甘草酸苷 25mg）、甘氨酸 25mg、DL-蛋氨酸25mg，Akiyama Jozai Co., Ltd. Head Factory 生产，Minophagen Pharmaceutical Co., Ltd.持证）在健康成年受试者体内的药代动力学，评价餐后口服两种制剂的生物等效性。
次要研究目的
评价健康受试者餐后单次口服受试制剂（T）复方甘草酸苷片和参比制剂（R）复方甘草酸苷片（美能®）后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation compound glycyrrhizin tablets (specifications: glycyrrhizic acid monoammonium salt 35mg (glycyrrhizic acid 25mg), glycine 25mg, DL-methionine 25mg, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd., licensed by Guangdong Yueheze Pharmaceutical Research Co., Ltd.) and the reference preparation compound glycyrrhizin tablets (trade name: Mei Neng®, specifications: glycyrrhizic acid monoammonium salt 35mg (glycyrrhizic acid 25mg), glycine 25mg, DL-methionine 25mg, produced by Akiyama Jozai Co., Ltd. Head Factory, licensed by Minophagen Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration after a meal.
Secondary study objectives
To evaluate the safety of the test preparation (T) compound glycyrrhizin tablets and the reference preparation (R) compound glycyrrhizin tablets (Meineng®) after a single oral administration in healthy subjects.
/ CompletedNot Applicable O-LFB在健康受试者中随机、开放、两制剂、单次给药、四周期、完全重复交叉空腹和餐后状态下生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, four-period, fully repeated crossover bioequivalence study of O-LFB in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹和餐后状态下单次口服受试制剂O-LFB（规格：15 mg，由深圳信立泰药业有限公司生产，广东粤和泽药物研究有限公司提供）与参比制剂O-LFB（Xarelto®，规格：15 mg；Bayer Pharma AG持证，广东粤和泽药物研究有限公司提供）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的
研究受试制剂O-LFB和参比制剂O-LFB（Xarelto®）在健康成年受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test formulation O-LFB (specification: 15 mg, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd., provided by Guangdong Yueheze Pharmaceutical Research Co., Ltd.) and the reference formulation O-LFB (Xarelto®, specification: 15 mg; licensed by Bayer Pharma AG, provided by Guangdong Yueheze Pharmaceutical Research Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two formulations in the fasting and fed state.
Secondary study objectives
To study the safety of the test formulation O-LFB and the reference formulation O-LFB (Xarelto®) in healthy adult subjects.
100 Clinical Results associated with Guangdong Yueheze Pharmaceutical Research Co., Ltd.
0 Patents (Medical) associated with Guangdong Yueheze Pharmaceutical Research Co., Ltd.
100 Deals associated with Guangdong Yueheze Pharmaceutical Research Co., Ltd.
100 Translational Medicine associated with Guangdong Yueheze Pharmaceutical Research Co., Ltd.
