维生素K1注射液在健康受试者中随机、开放、两制剂、两序列、交叉、空腹/餐后状态下口服生物等效性试验
[Translation] A randomized, open-label, two-formulation, two-sequence, crossover, fasting/fed oral bioequivalence study of vitamin K1 injection in healthy subjects
以海南全盈药业有限公司研制的维生素K1注射液（规格：1mL:10mg）为受试制剂（T），Cheplapharm Arzneimittel GmbH/Roche Pharma AG生产的维生素K1注射液（商品名：Konakion® MM 10mg；规格：1mL:10mg）为参比制剂（R），考察受试制剂和参比制剂在中国健康受试者空腹和餐后状态下单次口服给药的药代动力学参数，评价两制剂是否具有生物等效性，评估海南全盈药业有限公司研制的维生素K1注射液的安全性。
[Translation] The vitamin K1 injection (specification: 1mL:10mg) developed by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation (T), and the vitamin K1 injection (trade name: Konakion® MM 10mg; specification: 1mL:10mg) produced by Cheplapharm Arzneimittel GmbH/Roche Pharma AG was used as the reference preparation (R). The pharmacokinetic parameters of the test preparation and the reference preparation were investigated after single oral administration in Chinese healthy volunteers under fasting and postprandial conditions, and the bioequivalence of the two preparations was evaluated. The safety of the vitamin K1 injection developed by Hainan Quanying Pharmaceutical Co., Ltd. was assessed.
维生素K1注射液在健康受试者中随机、开放、两制剂、两序列、交叉、静脉注射给药的生物等效性试验
[Translation] A randomized, open-label, two-formulation, two-sequence, crossover, intravenous bioequivalence study of vitamin K1 injection in healthy subjects
以海南全盈药业有限公司研制的维生素K1注射液（规格：1mL:10mg）为受试制剂（T），Cheplapharm Arzneimittel GmbH/Roche Pharma AG生产的维生素K1注射液（商品名：Konakion® MM 10mg；规格：1mL:10mg）为参比制剂（R），考察受试制剂和参比制剂在中国健康受试者单次静脉注射给药的药代动力学参数，评价两制剂是否具有生物等效性，评估海南全盈药业有限公司研制的维生素K1注射液的安全性。
[Translation] The vitamin K1 injection (specification: 1mL:10mg) developed by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation (T), and the vitamin K1 injection (trade name: Konakion® MM 10mg; specification: 1mL:10mg) produced by Cheplapharm Arzneimittel GmbH/Roche Pharma AG was used as the reference preparation (R). The pharmacokinetic parameters of the test preparation and the reference preparation after a single intravenous injection in healthy Chinese subjects were investigated, the bioequivalence of the two preparations was evaluated, and the safety of the vitamin K1 injection developed by Hainan Quanying Pharmaceutical Co., Ltd. was assessed.
地奈德乳膏的生物等效性试验（剂量持续时间-效应研究/关键性生物等效性试验/药代动力学对比研究）
[Translation] Bioequivalence study of desonide cream (dose-duration-effect study/pivotal bioequivalence study/pharmacokinetic comparison study)
1）剂量持续时间-效应研究：以健康受试者为研究对象，以Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏（规格：0.05%，商品名：DESONIDE）为试验用药，通过观测收缩皮肤血管，致使皮肤变白的作用，探索达到半数最大效应（Emax）的剂量持续时间（ED50）；
2）关键性生物等效性试验：以健康受试者为研究对象，以海南全盈药业有限公司持有的地奈德乳膏（规格：0.05%）为受试制剂，Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏（规格：0.05%，商品名：DESONIDE）为参比制剂，通过比较收缩皮肤血管，致使皮肤变白的作用，评价受试制剂与参比制剂是否具有生物等效性；
3）药代动力学对比研究：以健康受试者为研究对象，以海南全盈药业有限公司持有的地奈德乳膏（规格：0.05%）为受试制剂，Perrigo New York Inc/Padagis US LLC持证的地奈德乳膏（规格：0.05%，商品名：DESONIDE）为参比制剂，通过药代动力学对比研究，评价受试制剂与参比制剂的体内暴露。
[Translation] 1) Dose-duration-effect study: healthy subjects were used as research subjects, and Desonide Cream (Specification: 0.05%, Trade Name: DESONIDE) licensed by Perrigo New York Inc/Padagis US LLC was used as the test drug. By observing the effect of contracting skin blood vessels and causing skin whitening, the dose duration (ED50) that reaches the half-maximum effect (Emax) was explored;
2) Pivotal bioequivalence trial: healthy subjects were used as research subjects, and Desonide Cream (Specification: 0.05%) owned by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation, and Desonide Cream (Specification: 0.05%, Trade Name: DESONIDE) licensed by Perrigo New York Inc/Padagis US LLC was used as the reference preparation. By comparing the effect of contracting skin blood vessels and causing skin whitening, the test preparation and the reference preparation were evaluated for bioequivalence;
3) Pharmacokinetic comparison study: healthy subjects were used as research subjects, and Desonide Cream (Specification: 0.05%) owned by Hainan Quanying Pharmaceutical Co., Ltd. was used as the test preparation, and Desonide Cream (Specification: 0.05%, Trade Name: DESONIDE) licensed by Perrigo New York Inc/Padagis US LLC was used as the reference preparation. By comparing the effect of contracting skin blood vessels and causing skin whitening, the test preparation and the reference preparation were evaluated for bioequivalence; Desonide cream (specification: 0.05%, trade name: DESONIDE) licensed by New York Inc/Padagis US LLC was used as the reference preparation. A pharmacokinetic comparison study was conducted to evaluate the in vivo exposure of the test preparation and the reference preparation.
100 Clinical Results associated with Hainan Quanying Pharmaceutical Co., Ltd
0 Patents (Medical) associated with Hainan Quanying Pharmaceutical Co., Ltd
100 Deals associated with Hainan Quanying Pharmaceutical Co., Ltd
100 Translational Medicine associated with Hainan Quanying Pharmaceutical Co., Ltd
