/ CompletedNot Applicable [Translation] Human bioequivalence study of loxoprofen sodium patch
主要目的：
比较空腹条件下湖南派格兰药业有限公司提供的受试制剂洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm））与LEAD CHEMICAL CO., LTD持证的参比制剂洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm））在健康参与者中吸收程度和吸收速度的差异，评价两制剂的生物等效性。
次要目的：
1）评价受试制剂与参比制剂在健康参与者用药过程中的黏附性；
2）评价受试制剂与参比制剂在健康参与者中的安全性；
3）评价受试制剂与参比制剂对健康参与者的皮肤刺激性。
[Translation] Primary Objective: To compare the absorption extent and rate of absorption of the test formulation loxoprofen sodium patch (100 mg/patch (10 cm × 14 cm)) provided by Hunan Paiglan Pharmaceutical Co., Ltd. and the reference formulation loxoprofen sodium patch (100 mg/patch (10 cm × 14 cm)) certified by LEAD CHEMICAL CO., LTD. in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Objectives:
1) To evaluate the adhesion of the test formulation and the reference formulation during administration to healthy participants;
2) To evaluate the safety of the test formulation and the reference formulation in healthy participants;
3) To evaluate the skin irritation of the test formulation and the reference formulation in healthy participants.
/ TerminatedNot Applicable [Translation] Human bioequivalence study of loxoprofen sodium patch
主要目的：
比较受试制剂湖南派格兰药业有限公司提供的洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm））与参比制剂Lead Chemical Co., Ltd持证的洛索洛芬钠贴剂（规格：100 mg/贴（10 cm×14 cm））在中国健康人群中吸收程度和吸收速度的差异。
次要目的：
1）评价受试制剂与参比制剂在健康参与者用药过程中的黏附性；
2）评价受试制剂与参比制剂在健康参与者中的安全性；
3）评价受试制剂与参比制剂对健康参与者的皮肤刺激性。
[Translation] Primary Objective: To compare the absorption extent and rate of absorption of the test formulation (loxoprofen sodium patch, 100 mg/patch (10 cm × 14 cm)) supplied by Hunan Paiglan Pharmaceutical Co., Ltd., and the reference formulation (loxoprofen sodium patch, 100 mg/patch (10 cm × 14 cm)) certified by Lead Chemical Co., Ltd., in a healthy Chinese population.
Secondary Objectives:
1) To evaluate the adhesion of the test and reference formulations during administration to healthy participants;
2) To evaluate the safety of the test and reference formulations in healthy participants;
3) To evaluate the skin irritation of the test and reference formulations in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of rotigotine patch in healthy volunteers
主要目的：
比较湖南派格兰药业有限公司提供的罗替高汀贴片（规格：4.5 mg/10 cm2（释药量2 mg/24 h））与UCB Pharma S.A.持证的罗替高汀贴片（商品名：NEUPRO®（优普洛）®；规格：4.5 mg/10 cm2（释药量2 mg/24 h））在中国健康人群吸收程度和吸收速度的差异，评价两制剂的生物等效性。
次要目的：
1）评价受试制剂与参比制剂在中国健康参与者中的安全性；2）评价受试制剂与参比制剂在中国健康参与者用药过程中的黏附性；3）评价受试制剂与参比制剂对中国健康参与者的皮肤刺激性。
[Translation] Primary Objectives:
To compare the extent and rate of absorption of the rotigotine patch (strength: 4.5 mg/10 cm² (drug release: 2 mg/24 h)) provided by Hunan Pageland Pharmaceutical Co., Ltd. and the rotigotine patch (trade name: NEUPRO®; strength: 4.5 mg/10 cm² (drug release: 2 mg/24 h)) licensed by UCB Pharma S.A. in healthy Chinese subjects, and to evaluate the bioequivalence of the two formulations.
Secondary Objectives:
1) To evaluate the safety of the test formulation and the reference formulation in healthy Chinese subjects; 2) To evaluate the adhesiveness of the test formulation and the reference formulation during use in healthy Chinese subjects; and 3) To evaluate the skin irritation of the test formulation and the reference formulation in healthy Chinese subjects.
100 Clinical Results associated with Hunan Paiglan Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hunan Paiglan Pharmaceutical Co., Ltd.
100 Deals associated with Hunan Paiglan Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hunan Paiglan Pharmaceutical Co., Ltd.
