磷酸奥司他韦胶囊在中国健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹状态下的药代动力学比较研究
[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover pharmacokinetic comparison study of oseltamivir phosphate capsules in healthy Chinese subjects under fasting conditions.
主要目的:空腹给药条件下,比较海南林恒制药股份有限公司提供的磷酸奥司他韦胶囊(规格:75 mg)与Roche Pharma (Schweiz) AG持证的磷酸奥司他韦胶囊(规格:75 mg)在健康成年人群中吸收程度和速度的差异,估算其药代动力学参数及个体内变异度,用于计算和调整正式试验样本量,同时验证分析方法、试验流程、采血点和试验设计的合理性。
次要目的:评价空腹给药条件下,海南林恒制药股份有限公司提供的磷酸奥司他韦胶囊(规格:75 mg)的安全性。
[Translation] Primary Objective: To compare the absorption rate and extent of oseltamivir phosphate capsules (75 mg) supplied by Hainan Linheng Pharmaceutical Co., Ltd. with those certified by Roche Pharma (Schweiz) AG in a healthy adult population under fasting administration conditions, estimate their pharmacokinetic parameters and intra-individual variability, calculate and adjust the sample size for the formal trial, and validate the rationality of the analytical methods, experimental procedures, blood collection points, and experimental design.
Secondary Objective: To evaluate the safety of oseltamivir phosphate capsules (75 mg) supplied by Hainan Linheng Pharmaceutical Co., Ltd. under fasting administration conditions.
/ Unknown statusNot ApplicableIIT Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets and Calcium Hydroxybenzene Sulfonate Tablets (Doxium®) Under Fed Conditions in Chinese Healthy Volunteers
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
/ CompletedNot Applicable 一项单中心、随机、开放、单剂量、两制剂、双周期、交叉研究评价羟苯磺酸钙分散片在健康人群中的生物等效性
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, crossover study to evaluate the bioequivalence of calcium dobesilate dispersible tablets in healthy subjects
以海南林恒制药股份有限公司生产的羟苯磺酸钙分散片作为受试制剂,OM pharma S.A.生产的羟苯磺酸钙片(商品名:Doxium ,规格:250mg/片)为参比制剂,评估两种制剂空腹和餐后给药的生物等效性。
[Translation] Calcium dobesilate dispersible tablets produced by Hainan Linheng Pharmaceutical Co., Ltd. were used as the test preparation, and calcium dobesilate tablets (trade name: Doxium, specification: 250 mg/tablet) produced by OM pharma S.A. were used as the reference preparation to evaluate the bioequivalence of the two preparations when administered on an empty stomach or after a meal.
100 Clinical Results associated with Hainan Linheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hainan Linheng Pharmaceutical Co., Ltd.
100 Deals associated with Hainan Linheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hainan Linheng Pharmaceutical Co., Ltd.