/ Not yet recruitingNot Applicable 醋酸锌片在健康研究参与者中空腹与餐后条件下开放、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 zinc acetate tablets in healthy study participants under fasting and fed conditions
研究空腹与餐后状态下单次口服受试制剂(醋酸锌片,规格50mg(按Zn计),北京远方通达医药技术有限公司持证)与参比制剂(醋酸锌片,规格50mg(按Zn计),商品名ノベルジン(NOBELZIN),ノーベルファーマ株式会社(Nobel Pharma Co., Ltd.)持证)在健康研究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,并研究药物在健康研究参与者体内的安全性。
[Translation] To study the pharmacokinetic characteristics of the test preparation (zinc acetate tablets, 50 mg (calculated as Zn), licensed by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.) and the reference preparation (zinc acetate tablets, 50 mg (calculated as Zn), trade name NOBELZIN, licensed by Nobel Pharma Co., Ltd.) in healthy research participants after a single oral administration in the fasting and fed state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy research participants.
/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of spironolactone oral suspension in healthy volunteers
主要目的:
比较空腹给药条件下北京远方通达医药技术有限公司提供的螺内酯口服混悬液(规格:118 mL:0.59 g)与Cmp Development Llc持证的螺内酯口服混悬液(商品名:CAROSPIR®;规格:25 mg/5 mL)在中国健康人群吸收程度和吸收速度的差异。
次要目的:
评价空腹给药条件下北京远方通达医药技术有限公司提供的螺内酯口服混悬液(规格:118 mL:0.59 g)与Cmp Development Llc持证的螺内酯口服混悬液(商品名:CAROSPIR®;规格:25 mg/5 mL)在健康研究参与者体内的安全性
[Translation] Primary objective:
To compare the differences in the extent and rate of absorption of spironolactone oral suspension (specification: 118 mL: 0.59 g) provided by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd. and spironolactone oral suspension (trade name: CAROSPIR®; specification: 25 mg/5 mL) licensed by Cmp Development Llc in healthy Chinese people under fasting conditions.
Secondary objective:
To evaluate the safety of spironolactone oral suspension (specification: 118 mL: 0.59 g) provided by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd. and spironolactone oral suspension (trade name: CAROSPIR®; specification: 25 mg/5 mL) licensed by Cmp Development Llc under fasting conditions in healthy study 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.
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.