/ CompletedNot Applicable [Translation] Study on the bioequivalence of leprocaine cream in healthy volunteers
主要目的:采用单中心、随机、开放、双周期交叉、空腹试验设计,比较空腹给药条件下,浙江寰领医药科技有限公司提供、浙江鼎泰药业股份有限公司生产的利丙双卡因乳膏(1 g:利多卡因25 mg,丙胺卡因25 mg)与Aspen Pharma Trading Limited持证的利丙双卡因乳膏(商品名:EMLA®,规格:1 g:利多卡因25 mg,丙胺卡因25 mg)在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:评价利丙双卡因乳膏(规格:1 g:利多卡因25 mg,丙胺卡因25 mg)受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of leprocaine cream (1 g: lidocaine 25 mg, prilocaine 25 mg) provided by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. and produced by Zhejiang Dingtai Pharmaceutical Co., Ltd. and leprocaine cream (trade name: EMLA®, specification: 1 g: lidocaine 25 mg, prilocaine 25 mg) certified by Aspen Pharma Trading Limited in healthy Chinese population under fasting administration conditions, and to evaluate bioequivalence.
Secondary objective: To evaluate the safety of the test and reference preparations of leprocaine cream (specification: 1 g: lidocaine 25 mg, prilocaine 25 mg) in healthy subjects.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of acetylcysteine granules in human body
分别采用单中心、随机、开放、双周期交叉、单次口服试验设计评价空腹和餐后给药条件下浙江寰领医药科技有限公司委托浙江亚峰药厂有限公司生产的乙酰半胱氨酸颗粒(规格:0.2 g)与海南赞邦制药有限公司生产的乙酰半胱氨酸颗粒(商品名:富露施®,规格:0.2 g)在健康人群中的吸收程度和吸收速度的差异。并评价空腹与餐后给药条件下浙江寰领医药科技有限公司委托浙江亚峰药厂有限公司生产的乙酰半胱氨酸颗粒(规格:0.2 g)的安全性与耐受性。
[Translation] A single-center, randomized, open, double-period crossover, single oral trial design was used to evaluate the differences in the degree and rate of absorption of acetylcysteine granules (specification: 0.2 g) produced by Zhejiang Yafeng Pharmaceutical Co., Ltd. and commissioned by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. and produced by Hainan Zanbang Pharmaceutical Co., Ltd. (trade name: Fulushi®, specification: 0.2 g) in healthy people under fasting and postprandial administration conditions. The safety and tolerability of acetylcysteine granules (specification: 0.2 g) produced by Zhejiang Yafeng Pharmaceutical Co., Ltd. commissioned by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. under fasting and postprandial administration conditions were also evaluated.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of ursodeoxycholic acid capsules in healthy volunteers
采用随机、开放、两周期交叉、单次口服试验设计比较空腹和餐后给药条件下,浙江寰领医药科技有限公司持证的熊去氧胆酸胶囊(0.25 g)与Losan Pharma GmbH生产的熊去氧胆酸胶囊(商品名:优思弗®,规格:250 mg)在中国健康人群吸收程度和吸收速度的差异,并评价浙江寰领医药科技有限公司的熊去氧胆酸胶囊的安全性。
[Translation] A randomized, open, two-period crossover, single oral trial design was used to compare the differences in absorption extent and absorption rate between ursodeoxycholic acid capsules (0.25 g) produced by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. and ursodeoxycholic acid capsules (trade name: Ursofol®, specification: 250 mg) produced by Losan Pharma GmbH in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of ursodeoxycholic acid capsules produced by Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
100 Clinical Results associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.