/ CompletedNot Applicable 艾司奥美拉唑镁肠溶胶囊(40 mg)健康人体生物等效性研究
[Translation] Bioequivalence study of esomeprazole magnesium enteric-coated capsules (40 mg) in healthy volunteers
主要目的:
本研究以桂林华信制药有限公司生产并持有的艾司奥美拉唑镁肠溶胶囊(规格:40 mg)为受试制剂,按生物等效性研究的有关规定,以AstraZeneca AB生产的艾司奥美拉唑镁肠溶胶囊(规格:40 mg,商品名:NEXIUM®)为参比制剂,评估受试制剂和参比制剂在空腹/空腹苹果酱/餐后状态下给药后的生物等效性。
次要目的:
观察受试制剂艾司奥美拉唑镁肠溶胶囊和参比制剂艾司奥美拉唑镁肠溶胶囊(NEXIUM®)在健康受试者中的安全性。
[Translation] Primary Objective:
This study used esomeprazole magnesium enteric-coated capsules (40 mg) produced and owned by Guilin Huaxin Pharmaceutical Co., Ltd. as the test formulation. In accordance with relevant bioequivalence regulations, esomeprazole magnesium enteric-coated capsules (40 mg, trade name: NEXIUM®) produced by AstraZeneca AB served as the reference formulation. The bioequivalence of the test and reference formulations was evaluated after administration in the fasting, fasting applesauce, and fed states.
Secondary Objective:
To observe the safety of the test and reference formulations, esomeprazole magnesium enteric-coated capsules, and esomeprazole magnesium enteric-coated capsules (NEXIUM®), in healthy volunteers.
/ CompletedNot Applicable 熊去氧胆酸口服混悬液在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of ursodeoxycholic acid oral suspension in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由桂林华信制药有限公司提供的熊去氧胆酸口服混悬液(受试制剂T,规格:250mL:12.5g,按C24H40O4计)与相同条件下单次口服由Dr. Falk Pharma GmbH.持证的熊去氧胆酸口服混悬液(参比制剂R,商品名:Ursofalk®,规格:250mL:12.5g,按C24H40O4计)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] The pharmacokinetic characteristics of ursodeoxycholic acid oral suspension (test preparation T, strength: 250mL: 12.5g, calculated as C24H40O4) provided by Guilin Huaxin Pharmaceutical Co., Ltd. and ursodeoxycholic acid oral suspension (reference preparation R, trade name: Ursofalk®, strength: 250mL: 12.5g, calculated as C24H40O4) certified by Dr. Falk Pharma GmbH were investigated in healthy subjects under fasting and postprandial conditions. The bioequivalence and safety of the two preparations were evaluated to provide a basis for the registration application of the test preparation.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of fexofenadine hydrochloride oral suspension in healthy volunteers
主要目的:
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口服混悬液(规格:120 mL:0.72 g)与Sanofi Aventis U.S.LL持证的盐酸非索非那定口服混悬液(商品名:Children's Allegra Allergy®;规格:30 mg/5 mL)在中国健康人群吸收程度和吸收速度的差异。
次要目的:
评价空腹及餐后条件下,桂林华信制药有限公司提供的盐酸非索非那定口服混悬液(规格:120 mL:0.72 g)与Sanofi Aventis U.S.LL持证的盐酸非索非那定口服混悬液(商品名:Children's Allegra Allergy®;规格:30 mg/5 mL)在中国健康参与者体内的安全性。评价盐酸非索非那定口服混悬液在中国健康人群中的适口性,为盐酸非索非那定口服混悬液用药口感提供依据。
[Translation] Primary Objective:
To compare the extent and rate of absorption of fexofenadine hydrochloride oral suspension (120 mL, 0.72 g) supplied by Guilin Huaxin Pharmaceutical Co., Ltd. and fexofenadine hydrochloride oral suspension (trade name: Children's Allegra Allergy®; strength: 30 mg/5 mL) licensed by Sanofi Aventis U.S. LLC in healthy Chinese subjects, under fasting and fed conditions.
Secondary Objective:
To evaluate the safety of fexofenadine hydrochloride oral suspension (120 mL, 0.72 g) supplied by Guilin Huaxin Pharmaceutical Co., Ltd. and fexofenadine hydrochloride oral suspension (trade name: Children's Allegra Allergy®; strength: 30 mg/5 mL) licensed by Sanofi Aventis U.S. LLC in healthy Chinese subjects, under fasting and fed conditions. To evaluate the palatability of fexofenadine hydrochloride oral suspension in healthy Chinese subjects and provide a basis for the taste of fexofenadine hydrochloride oral suspension.
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.