[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.
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.
CG2001在中国成年男性雄激素性脱发受试者中单次和多次给药的随机、双盲、安慰剂对照I期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase I clinical study of single and multiple doses of CG2001 in Chinese adult male subjects with androgenetic alopecia
主要研究目的:评价单次及多次局部涂抹给予CG2001在男性雄激素性脱发受试者中的安全性和耐受性。
次要研究目的:评价单次及多次局部涂抹给予CG2001在男性雄激素性脱发受试者中的药代动力学(PK)特征。
[Translation] Primary study objective: To evaluate the safety and tolerability of CG2001 in male subjects with androgenetic alopecia after single and multiple topical applications.
Secondary study objective: To evaluate the pharmacokinetic (PK) characteristics of CG2001 in male subjects with androgenetic alopecia after single and multiple topical applications.
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.