/ CompletedNot Applicable [Translation] Bioequivalence study of benidipine hydrochloride tablets (8 mg) in healthy volunteers
主要目的:
本研究以桂林华信制药有限公司持有,桂林华信制药有限公司生产的盐酸贝尼地平片(规格:8 mg)为受试制剂,按生物等效性研究有关规定,以Kyowa Kirin Co.,Ltd.持有的盐酸贝尼地平片(规格:8 mg,商品名:可力洛® /Coniel®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:
观察受试制剂盐酸贝尼地平片和参比制剂盐酸贝尼地平片(可力洛® /Coniel®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used benidipine hydrochloride tablets (specification: 8 mg) owned by Guilin Huaxin Pharmaceutical Co., Ltd. and produced by Guilin Huaxin Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, benidipine hydrochloride tablets (specification: 8 mg, trade name: Coniel® /Coniel®) owned by Kyowa Kirin Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose:
Observe the safety of the test preparation benidipine hydrochloride tablets and the reference preparation benidipine hydrochloride tablets (Coniel® /Coniel®) in healthy subjects.
/ CompletedNot Applicable 坎地氢噻片(16 mg/12.5 mg)健康人体生物等效性研究
[Translation] Bioequivalence study of candecitabine tablets (16 mg/12.5 mg) in healthy volunteers
本研究以桂林华信制药有限公司研制的坎地氢噻片(规格:每片含坎地沙坦酯16 mg,氢氯噻嗪12.5 mg)为受试制剂,按生物等效性研究的有关规定,以CHEPLAPHARM Arzneimittel GmbH持有,Delpharm Novara S.r.l.生产的坎地氢噻片(规格:每片含坎地沙坦酯16 mg,氢氯噻嗪12.5 mg,商品名称:Blopress®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
[Translation] In this study, Candesartan cilexetil tablets (specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) developed by Guilin Huaxin Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, Candesartan cilexetil tablets (specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide, trade name: Blopress®) owned by CHEPHAPHARM Arzneimittel GmbH and produced by Delpharm Novara S.r.l. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of fexofenadine hydrochloride dry suspension in healthy volunteers
比较空腹和餐后给药条件下,桂林华信制药有限公司提供的盐酸非索非那定干混悬剂(30 mg)与サノフィ株式会社(赛诺菲株式会社)持证生产的盐酸非索非那定干糖浆(商品名:Allegra®,规格:30 mg/0.6 g)在中国健康人群吸收程度和吸收速度的差异,并评价桂林华信制药有限公司的盐酸非索非那定干混悬剂的安全性。
[Translation] To compare the differences in absorption extent and rate between the fexofenadine hydrochloride dry suspension (30 mg) provided by Guilin Huaxin Pharmaceutical Co., Ltd. and the fexofenadine hydrochloride dry syrup (trade name: Allegra®, specification: 30 mg/0.6 g) produced by Sanofi Co., Ltd. under fasting and postprandial administration in healthy Chinese people, and to evaluate the safety of the fexofenadine hydrochloride dry suspension produced by Guilin Huaxin Pharmaceutical Co., Ltd.
100 Clinical Results associated with Guilin Huaxin Pharmacy Co. Ltd.
0 Patents (Medical) associated with Guilin Huaxin Pharmacy Co. Ltd.
100 Deals associated with Guilin Huaxin Pharmacy Co. Ltd.
100 Translational Medicine associated with Guilin Huaxin Pharmacy Co. Ltd.