/ Active, not recruitingNot Applicable 磷苯妥英钠注射液在中国健康受试者中单次肌肉注射给药的、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of fosphenytoin sodium injection in healthy Chinese subjects after a single intramuscular injection
主要目的:以海南慧通生物医药科技有限公司研制的磷苯妥英钠注射液(规格:10 mL:500 mg(按C15H11N2NaO2计))为受试制剂(T),Parke Davis Div Warner Lambert Co持证的磷苯妥英钠注射液(商品名:Cerebyx®,规格:10 mL:500 mg(按C15H11N2NaO2计))为参比制剂(R),研究受试制剂和参比制剂肌肉注射时的药代动力学参数,评价两制剂的人体生物等效性。
次要目的:评估海南慧通生物医药科技有限公司研制的磷苯妥英钠注射液在中国健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic parameters of the test and reference preparations when injected intramuscularly, and to evaluate the bioequivalence of the two preparations in humans, using fosphenytoin sodium injection (specification: 10 mL: 500 mg (calculated as C15H11N2NaO2)) developed by Hainan Huitong Biopharmaceutical Technology Co. as the test preparation (T) and fosphenytoin sodium injection (trade name: Cerebyx®, specification: 10 mL: 500 mg (calculated as C15H11N2NaO2)) licensed by Parke Davis Div Warner Lambert Co as the reference preparation (R).
Secondary objective: To evaluate the safety of fosphenytoin sodium injection developed by Hainan Huitong Biopharmaceutical Technology Co. in healthy Chinese subjects.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of sildenafil citrate orodispersible film in healthy volunteers
主要目的:
比较空腹和餐后给药条件下海南慧通生物医药科技有限公司提供的枸橼酸西地那非口溶膜(规格:50 mg)与ヴィアトリス製薬株式会社持证的枸橼酸西地那非口溶膜(商品名:Viagra®;规格:50 mg)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,海南慧通生物医药科技有限公司提供的枸橼酸西地那非口溶膜(规格:50 mg)与ヴィアトリス製薬株式会社持证的枸橼酸西地那非口溶膜(商品名:Viagra®;规格:50 mg)在健康受试者体内的安全性。
评价枸橼酸西地那非口溶膜在中国健康人群中的适口性,为枸橼酸西地那非口溶膜用药口感提供依据。
[Translation] Main purpose: To compare the differences in absorption degree and absorption rate between the sildenafil citrate orodispersible film (specification: 50 mg) provided by Hainan Huitong Biopharmaceutical Technology Co., Ltd. and the sildenafil citrate orodispersible film (trade name: Viagra®; specification: 50 mg) certified by Viatris Pharmaceutical Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions.
Secondary objective:
To evaluate the safety of sildenafil citrate orodispersible film (specification: 50 mg) provided by Hainan Huitong Biopharmaceutical Technology Co., Ltd. and sildenafil citrate orodispersible film (trade name: Viagra®; specification: 50 mg) certified by Viatris Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions.
To evaluate the palatability of sildenafil citrate orodispersible film in healthy Chinese people and provide a basis for the taste of sildenafil citrate orodispersible film.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of carbocycline-levodopa sustained-release tablets in healthy volunteers
主要目的:空腹试验采用单中心、随机、开放、单剂量、四周期完全重复交叉设计,餐后试验采用单中心、随机、开放、单剂量、两周期交叉设计,比较海南慧通生物医药科技有限公司委托湖南九典制药股份有限公司生产的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg)与MSD Pharma(Singapore) Pte. Ltd.持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg;商品名:Sinemet®/息宁®)在健康人群中吸收程度和速度的差异。 次要目的:评价空腹及餐后条件下,海南慧通生物医药科技有限公司委托湖南九典制药股份有限公司生产的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg)与MSD Pharma(Singapore) Pte. Ltd.持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg;商品名:Sinemet®/息宁®)的安全性和耐受性。
[Translation] Main objective: The fasting trial adopted a single-center, randomized, open, single-dose, four-period completely repeated crossover design, and the postprandial trial adopted a single-center, randomized, open, single-dose, two-period crossover design to compare the differences in absorption degree and speed between the carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Hunan Jiudian Pharmaceutical Co., Ltd. and the carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa; trade name: Sinemet®/Xining®) certified by MSD Pharma (Singapore) Pte. Ltd. in healthy people. Secondary objective: To evaluate the safety and tolerability of carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Hunan Jiudian Pharmaceutical Co., Ltd. and carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa; trade name: Sinemet®) certified by MSD Pharma (Singapore) Pte. Ltd. under fasting and postprandial conditions.
100 Clinical Results associated with Hainan Huitong Biomedical Technology Co., Ltd
0 Patents (Medical) associated with Hainan Huitong Biomedical Technology Co., Ltd
100 Deals associated with Hainan Huitong Biomedical Technology Co., Ltd
100 Translational Medicine associated with Hainan Huitong Biomedical Technology Co., Ltd