/ Active, not recruitingNot Applicable 评价阿齐沙坦氨氯地平片在中国成年健康参与者中的一项单中心、随机、开放、空腹和餐后条件下单次给药、两制剂、两周期交叉的生物等效性试验。
[Translation] To evaluate the bioequivalence of azisartan amlodipine tablets in healthy adult participants in China under fasting and postprandial conditions in a single-dose, two-formulation, two-period crossover trial.
主要试验目的：
考察单次单剂量口服（空腹和餐后）受试制剂阿齐沙坦氨氯地平片【规格：每片含阿齐沙坦20mg、氨氯地平5mg，安徽佳和药业有限公司生产】与参比制剂阿齐沙坦氨氯地平片【商品名：Zacras®，规格：每片含阿齐沙坦20mg、氨氯地平5mg，武田薬品工業株式会社持证】在中国健康人体的相对生物利用度试验，分析两种制剂的药代动力学参数，评价两制剂是否具有生物等效性。
次要试验目的：
评价在空腹与餐后条件下单次口服1片受试制剂和参比制剂在中国成年健康参与者中的安全性。
[Translation] Primary objective: To investigate the relative bioavailability of the test formulation, azilsartan-amlodipine tablets [specification: each tablet contains 20 mg azilsartan and 5 mg amlodipine, manufactured by Anhui Jiahe Pharmaceutical Co., Ltd.], and the reference formulation, azilsartan-amlodipine tablets [trade name: Zacas®, specification: each tablet contains 20 mg azilsartan and 5 mg amlodipine, licensed by Takeda Pharmaceutical Company Limited], in healthy Chinese subjects after a single oral dose (fasting and postprandial). Pharmacokinetic parameters of the two formulations will be analyzed to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of a single oral dose of one tablet of the test formulation and the reference formulation under fasting and postprandial conditions in healthy adult participants in China.
/ CompletedNot Applicable [Translation] Human bioequivalence study of candelabiol tablets
以中国健康试验参与者为试验对象，采用自身交叉对照的试验设计，测定坎地氢噻片受试制剂给药后血浆中的坎地沙坦和氢氯噻嗪在健康试验参与者体内的血药浓度经时过程，估算相应的药代动力学参数，并以CHEPLAPHARM Arzneimittel GmbH持证，Delpharm Novara S.r.l.生产的坎地氢噻片（商品名：Blopress®，规格：每片含坎地沙坦酯8mg，氢氯噻嗪12.5 mg）为参比，评价制剂间的生物等效性，并观察坎地氢噻片在中国健康试验参与者中的安全性。
[Translation] Using healthy participants in a Chinese trial, a self-controlled crossover study was conducted to determine the plasma concentrations of candesartan and hydrochlorothiazide in healthy participants over time after administration of the test formulation of candesartan medoxomil tablets. Corresponding pharmacokinetic parameters were estimated. Candesartan medoxomil tablets (trade name: Blopress®, specification: 8 mg candesartan medoxomil and 12.5 mg hydrochlorothiazide per tablet), manufactured by Delpharm Novara S.r.l. and licensed by CHEPLAPHARM Arzneimittel GmbH, were used as a reference to evaluate the bioequivalence between the formulations and to observe the safety of candesartan medoxomil tablets in healthy participants in the Chinese trial.
/ CompletedNot Applicable [Translation] Human bioequivalence study of candelabiol tablets
以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定坎地氢噻片受试制剂给药后血浆中的坎地沙坦和氢氯噻嗪在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以CHEPLAPHARM Arzneimittel GmbH持证，Delpharm Novara S.r.l.生产的坎地氢噻片（商品名：Blopress®，规格：每片含坎地沙坦酯16 mg，氢氯噻嗪12.5 mg）为参比，评价制剂间的生物等效性，并观察坎地氢噻片在中国健康受试者中的安全性。
[Translation] Using healthy Chinese subjects as subjects, a self-crossover controlled trial design was employed to determine the plasma concentrations of candesartan and hydrochlorothiazide in healthy subjects over time after administration of the test formulation of candesartan oxaliplatin tablets. Corresponding pharmacokinetic parameters were estimated. Candesartan oxaliplatin tablets (trade name: Blopress®, specification: 16 mg candesartan oxaliplatin and 12.5 mg hydrochlorothiazide per tablet), manufactured by Delpharm Novara S.r.l. and licensed by CHEPLAPHARM Arzneimittel GmbH, were used as a reference to evaluate the bioequivalence between the formulations and to observe the safety of candesartan oxaliplatin tablets in healthy Chinese subjects.
100 Clinical Results associated with Anhui Jiahe Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Anhui Jiahe Pharmaceutical Co., Ltd.
100 Deals associated with Anhui Jiahe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Anhui Jiahe Pharmaceutical Co., Ltd.
