评价CG2001治疗中国成年男性雄激素性脱发受试者的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅱ期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of CG2001 in the treatment of androgenetic alopecia in Chinese adult male subjects
主要目的
评估CG2001治疗中国成年男性雄激素性脱发（AGA）受试者的有效性，并确定Ⅲ期临床推荐给药剂量。
次要目的
评估目标剂量下CG2001治疗中国成年男性AGA受试者的安全性。
[Translation] Primary objective
To evaluate the efficacy of CG2001 in treating Chinese adult male subjects with androgenetic alopecia (AGA) and determine the recommended dose for Phase III clinical trials.
Secondary objective
To evaluate the safety of CG2201 in treating Chinese adult male subjects with AGA at the target dose.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of fexofenadine hydrochloride dry suspension in healthy volunteers
主要目的：
采用单中心、随机、开放、两周期交叉、单剂量、空腹及餐后给药设计，比较辰光（天津）制药有限公司提供的盐酸非索非那定干混悬剂（30 mg）与サノフィ株式会社（赛诺菲株式会社）持证生产的盐酸非索非那定干糖浆（商品名：Allegra®，规格：30 mg）在中国健康人群中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，辰光（天津）制药有限公司提供的盐酸非索非那定干混悬剂（规格：30 mg）与サノフィ株式会社（赛诺菲株式会社）持证生产的盐酸非索非那定干糖浆（商品名：Allegra®，规格：30 mg）的安全性。
[Translation] Main purpose:
A single-center, randomized, open, two-period crossover, single-dose, fasting and postprandial administration design was used to compare the differences in the degree and rate of absorption of fexofenadine hydrochloride dry suspension (30 mg) provided by Chenguang (Tianjin) Pharmaceutical Co., Ltd. and fexofenadine hydrochloride dry syrup (trade name: Allegra®, specification: 30 mg) produced by Sanofi Co., Ltd. in healthy Chinese people.
Secondary purpose:
Evaluate the safety of fexofenadine hydrochloride dry suspension (specification: 30 mg) provided by Chenguang (Tianjin) Pharmaceutical Co., Ltd. and fexofenadine hydrochloride dry syrup (trade name: Allegra®, specification: 30 mg) produced by Sanofi Co., Ltd. under fasting and postprandial conditions.
/ CompletedNot Applicable 非那雄胺片在中国健康受试者中单中心、随机、开放、单次给药、两周期、双交叉的空腹和餐后状态下生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of finasteride tablets in Chinese healthy subjects under fasting and fed conditions
主要目的：本研究以辰光（天津）制药有限公司的非那雄胺片（5mg）为受试制剂，Merck Sharp & Dohme Limited持证的非那雄胺片（商品名：保列治®，规格：5mg）为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。
次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used finasteride tablets (5 mg) from Chenguang (Tianjin) Pharmaceutical Co., Ltd. as the test preparation and finasteride tablets (trade name: Proscar®, specification: 5 mg) from Merck Sharp & Dohme Limited as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Chenguang (Tianjin) Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Chenguang (Tianjin) Pharmaceutical Co., Ltd.
100 Deals associated with Chenguang (Tianjin) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Chenguang (Tianjin) Pharmaceutical Co., Ltd.
