/ Not yet recruitingNot Applicable 乙酰半胱氨酸片在健康受试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 acetylcysteine tablets in healthy subjects under fasting conditions
研究空腹状态下单次口服受试制剂(乙酰半胱氨酸片,规格0.6g,华益药业科技(安徽)有限公司生产)与参比制剂(乙酰半胱氨酸片,规格600mg,商品名:Fluimucil,Zambon S.p.A.生产)在健康受试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,并研究药物在健康受试者体内的安全性。
[Translation] The pharmacokinetic characteristics of a single oral dose of the test preparation (acetylcysteine tablets, specification 0.6g, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (acetylcysteine tablets, specification 600mg, trade name: Fluimucil, produced by Zambon S.p.A.) in healthy subjects under fasting state were studied, the bioequivalence of the test preparation and the reference preparation was compared, and the safety of the drug in healthy subjects was studied.
/ RecruitingNot Applicable 盐酸曲唑酮缓释片在健康受试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 trazodone hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions
研究空腹与餐后状态下单次口服受试制剂(盐酸曲唑酮缓释片,规格0.15g,华益药业科技(安徽)有限公司持证)与参比制剂(盐酸曲唑酮缓释片,规格150mg,商品名曲特恪®,AZ. Chim. Riun. Angelini Francesco Acraf S.P.A.持证)在健康受试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,并研究药物在健康受试者体内的安全性。
[Translation] The pharmacokinetic characteristics of the test preparation (trazodone hydrochloride sustained-release tablets, specification 0.15g, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (trazodone hydrochloride sustained-release tablets, specification 150mg, trade name Trazodone®, licensed by AZ. Chim. Riun. Angelini Francesco Acraf S.P.A.) were studied in healthy subjects after a single oral dose in fasting and postprandial states, the bioequivalence of the test preparation and the reference preparation was compared, and the safety of the drug in healthy subjects was studied.
/ CompletedNot Applicable 依巴斯汀片在健康受试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 ebastine tablets in healthy subjects under fasting and fed conditions
研究空腹与餐后状态下单次口服受试制剂(依巴斯汀片,规格10mg,华益药业科技(安徽)有限公司生产)与参比制剂(依巴斯汀片,规格10mg,商品名Kestine,ALMIRALL,S.A.持证)在健康受试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,并研究药物在健康受试者体内的安全性。
[Translation] The pharmacokinetic characteristics of the test preparation (ebastine tablets, specification 10 mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (ebastine tablets, specification 10 mg, trade name Kestine, certified by ALMIRALL, S.A.) were studied in healthy subjects after a single oral administration under fasting and fed conditions, the bioequivalence of the test preparation and the reference preparation was compared, and the safety of the drug in healthy subjects was studied.
100 Clinical Results associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.
0 Patents (Medical) associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.
100 Deals associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.
100 Translational Medicine associated with Huayi Pharmaceutical Technology (Anhui) Co., Ltd.