[Translation] Bioequivalence study of fexofenadine hydrochloride oral suspension in Chinese healthy subjects in the fasting state with a randomized, open-label, single-dose, two-dose, three-sequence, three-period, partially repeated crossover design and in the fed state with a randomized, open-label, single-dose, two-dose, two-sequence, two-period crossover design.

主要目的：在中国健康受试者中评价哈尔滨葵花药业有限公司委托葵花药业集团重庆小葵花儿童制药有限公司生产的盐酸非索非那定口服混悬液（受试制剂，120ml：0.72g）与美国上市盐酸非索非那定口服混悬液（参比制剂，Children's Allegra® Allergy，30mg/5ml）的人体生物等效性。次要目的：观察盐酸非索非那定口服混悬液受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of fexofenadine hydrochloride oral suspension (test preparation, 120ml: 0.72g) produced by Chongqing Xiaokuihua Children's Pharmaceutical Co., Ltd. of Sunflower Pharmaceutical Group and commissioned by Harbin Sunflower Pharmaceutical Co., Ltd. with fexofenadine hydrochloride oral suspension (reference preparation, Children's Allegra® Allergy, 30mg/5ml) marketed in the United States in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and reference preparation of fexofenadine hydrochloride oral suspension in healthy Chinese subjects.

Start Date17 Oct 2023

Sponsor / Collaborator

Harbin Sunflower Pharmaceutical Co., Ltd.

CTR20230913 / CompletedNot Applicable

布洛芬混悬滴剂在中国成年健康受试者中的一项单中心、随机、开放、两周期、两序列、交叉、单次空腹/餐后给药生物等效性研究。

[Translation] A single-center, randomized, open-label, two-period, two-sequence, crossover, single fasting/fed administration bioequivalence study of ibuprofen suspension drops in healthy Chinese adult subjects.

主要目的：本研究以哈尔滨葵花药业有限公司研发的布洛芬混悬滴剂（规格： 15 ml：0.6 g）为受试制剂，按生物等效性研究的有关规定，以原研企业Johnson &Johnson Consumer Inc., McNeil Consumer Healthcare Division生产的布洛芬混悬滴剂（商品名： Motrin®，规格： 50 mg/1.25 mL ）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：观察受试制剂布洛芬混悬滴剂和参比制剂布洛芬混悬滴剂（商品名：Motrin®）在健康受试者中的安全性。

[Translation]

Primary objective: This study used ibuprofen suspension drops (specification: 15 ml: 0.6 g) developed by Harbin Sunflower Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, the ibuprofen suspension drops (trade name: Motrin®, specification: 50 mg/1.25 mL) produced by the original research company Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation ibuprofen suspension drops and the reference preparation ibuprofen suspension drops (trade name: Motrin®) in healthy subjects.

Start Date04 May 2023

Sponsor / Collaborator

Harbin Sunflower Pharmaceutical Co., Ltd.

CTR20230873 / CompletedNot Applicable

布洛芬混悬液在健康成年受试者中进行的单中心、随机、开放、两周期、两序列、交叉、单次给药试验设计，评价空腹/餐后状态下的生物等效性研究。

[Translation] This is a single-center, randomized, open-label, two-period, two-sequence, crossover, single-dose study designed to evaluate the bioequivalence of ibuprofen suspension in the fasting/fed state in healthy adult subjects.

主要目的：本研究以哈尔滨葵花药业有限公司研发的布洛芬混悬液（规格： 100 ml： 2g）为受试制剂，按生物等效性研究的有关规定，以原研厂家上海强生制药有限公司生产的布洛芬混悬液（规格： 100ml： 2 g，商品名称：美林®）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：观察受试制剂布洛芬混悬液和参比制剂布洛芬混悬液（美林®）在健康受试者中的安全性。

[Translation]

Primary objective: This study used ibuprofen suspension (specification: 100 ml: 2g) developed by Harbin Sunflower Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, ibuprofen suspension (specification: 100ml: 2 g, trade name: Meilin®) produced by the original manufacturer Shanghai Johnson Pharmaceutical Co., Ltd. was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation ibuprofen suspension and the reference preparation ibuprofen suspension (Meilin®) in healthy subjects.

Start Date24 Mar 2023

Sponsor / Collaborator

Harbin Sunflower Pharmaceutical Co., Ltd.

100 Clinical Results associated with Harbin Sunflower Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Harbin Sunflower Pharmaceutical Co., Ltd.

100 Deals associated with Harbin Sunflower Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Harbin Sunflower Pharmaceutical Co., Ltd.

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