/ RecruitingNot Applicable 米诺膦酸片在空腹给药条件下随机、开放、单剂量、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence study of minodronic acid tablets under fasting conditions
主要研究目的:以アステラス製薬株式会社生产的米诺膦酸片(商品名:Bonoteo,规格:1mg/片)为参比制剂,以安徽博诺美科生物医药有限公司提供的米诺膦酸片(规格:1mg/片)为受试制剂,采用随机、开放、单剂量、四周期、完全重复交叉设计,比较受试者空腹状态下服用受试制剂与参比制剂后米诺膦酸的吸收速度与程度,评价两制剂在中国健康受试者中空腹状态下的生物等效性。
次要研究目的:评价中国健康受试者口服受试制剂米诺膦酸片(规格:1mg/片)和参比制剂米诺膦酸片(商品名:Bonoteo,规格:1mg/片)的安全性。
[Translation] Main research purpose: Use minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) produced by Aisuo Biotech Co., Ltd. as the reference preparation, and use minodronic acid provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. The tablet (specification: 1 mg/tablet) is the test preparation. A randomized, open-label, single-dose, four-cycle, fully repeated crossover design was adopted to compare the effects of minodronic acid after subjects took the test preparation and the reference preparation in the fasting state. The absorption rate and extent were evaluated to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting state.
Secondary research purpose: To evaluate the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.
/ CompletedNot Applicable 米诺膦酸片在空腹给药条件下随机、开放、单剂量、四周期、完全重复交叉生物等效性预试验
[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence pilot study of minodronic acid tablets under fasting conditions
主要研究目的:以アステラス製薬株式会社生产的米诺膦酸片(商品名:Bonoteo,规格:1mg/片)为参比制剂,以安徽博诺美科生物医药有限公司提供的米诺膦酸片(规格:1mg/片)为受试制剂,采用随机、开放、单剂量、四周期、完全重复交叉设计,比较受试者空腹状态下服用受试制剂与参比制剂后米诺膦酸的吸收速度与程度,考察关键药动学参数的个体内变异度,为正式试验样本量确定及试验方案优化提供依据。
次要研究目的:观察中国健康受试者口服受试制剂米诺膦酸片(规格:1mg/片)和参比制剂米诺膦酸片(商品名:Bonoteo,规格:1mg/片)的安全性。
[Translation] Main research purpose: Use minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) produced by Aisuo Biotech Co., Ltd. as the reference preparation, and use minodronic acid provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. The tablet (specification: 1 mg/tablet) is the test preparation. A randomized, open-label, single-dose, four-cycle, fully repeated crossover design was adopted to compare the effects of minodronic acid after subjects took the test preparation and the reference preparation in the fasting state. The absorption speed and extent, and the intra-individual variability of key pharmacokinetic parameters are examined to provide a basis for determining the sample size of the formal test and optimizing the test plan.
Secondary research purpose: To observe the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.
/ RecruitingNot Applicable 比索洛尔氨氯地平片在空腹和餐后给药条件下随机、开放、单剂量、两周期双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period double-crossover bioequivalence study of bisoprolol and amlodipine tablets under fasting and fed conditions
主要研究目的:以持证商Merck Kft,Egis Pharmaceuticals PLC生产的比索洛尔氨氯地平片(商品名:康忻安®、规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)为参比制剂,以安徽博诺美科生物医药有限公司提供的比索洛尔氨氯地平片(规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)为受试制剂,采用随机、开放、单剂量、两周期双交叉设计,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要研究目的:评价口服受试制剂比索洛尔氨氯地平片(规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)和参比制剂(商品名:康忻安®、规格:富马酸比索洛尔5mg与苯磺酸氨氯地平(按氨氯地平计)5mg)在中国健康受试者中的安全性。
[Translation] Main research purpose: Using bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) produced by licensed manufacturer Merck Kft, Egis Pharmaceuticals PLC as reference preparation, and bisoprolol amlodipine tablets (specifications: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. as test preparation, a randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and fed states in healthy Chinese subjects.
Secondary study objective: To evaluate the safety of the oral test preparation bisoprolol amlodipine tablets (specifications: bisoprolol fumarate 5 mg and amlodipine besylate (calculated as amlodipine) 5 mg) and the reference preparation (trade name: Kangxinan®, specifications: bisoprolol fumarate 5 mg and amlodipine besylate (calculated as amlodipine) 5 mg) in healthy Chinese subjects.
100 Clinical Results associated with Anhui Bonomic Biomedical Co., Ltd.
0 Patents (Medical) associated with Anhui Bonomic Biomedical Co., Ltd.
100 Deals associated with Anhui Bonomic Biomedical Co., Ltd.
100 Translational Medicine associated with Anhui Bonomic Biomedical Co., Ltd.