克霉唑阴道片治疗外阴阴道假丝酵母菌病（VVC）有效性和安全性的随机、双盲、阳性药/安慰剂平行对照、多中心临床试验
[Translation] A randomized, double-blind, active-drug/placebo parallel-controlled, multicenter clinical trial to assess the efficacy and safety of clotrimazole vaginal tablets in the treatment of vulvovaginal candidiasis (VVC).
主要目的：以株洲千金药业股份有限公司提供的克霉唑阴道片为受试制剂，Bayer Vital GmbH持证的克霉唑阴道片（商品名：Canesten®/凯妮汀®）为参比制剂，在外阴阴道假丝酵母菌病（VVC）患者中，通过比较临床终点，评价两种克霉唑阴道片的生物等效性。同时验证受试制剂和参比制剂对VVC的治愈率优效于安慰剂。
次要目的：评价外阴阴道假丝酵母菌病（VVC）患者使用克霉唑阴道片受试制剂和参比制剂后的安全性。
[Translation] Primary Objective: To evaluate the bioequivalence of clotrimazole vaginal tablets (supplied by Zhuzhou Qianjin Pharmaceutical Co., Ltd.) and clotrimazole vaginal tablets (trade name: Canesten®) certified by Bayer Vital GmbH in patients with vulvovaginal candidiasis (VVC) by comparing clinical endpoints. Simultaneously, to verify that the investigational and reference formulations are superior to placebo in achieving a cure rate for VVC.
Secondary Objective: To evaluate the safety of clotrimazole vaginal tablets (investigation and reference formulations) in patients with vulvovaginal candidiasis (VVC).
/ RecruitingNot Applicable 氯化钾缓释胶囊（0.75g）在中国健康试验参与者中空腹及空腹撒布给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of potassium chloride sustained-release capsules (0.75g) in healthy Chinese participants under fasting and fasting sprinkle-on administration conditions.
主要研究目的：按有关生物等效性试验的规定，选择Actavis Laboratories Fl Inc为持证商的氯化钾缓释胶囊（规格：750mg）为参比制剂，对浙江诺得药业有限公司生产，浙江众延医药科技有限公司提供的受试制剂氯化钾缓释胶囊（规格：0.75g）进行空腹和空腹撒布给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和空腹撒布给药条件下的生物等效性。
次要研究目的：观察健康试验参与者口服受试制剂氯化钾缓释胶囊（规格：0.75g）和参比制剂氯化钾缓释胶囊（规格：750mg）的安全性。
[Translation] Primary Objective: In accordance with relevant bioequivalence testing regulations, potassium chloride sustained-release capsules (750 mg), manufactured by Actavis Laboratories Fl Inc., was selected as the reference formulation. A human bioequivalence study was conducted on the test formulation, potassium chloride sustained-release capsules (0.75 g), manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd. and provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd., under both fasting and fasting topical administration conditions. The study compared the absorption rate and extent of absorption of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, and evaluated the bioequivalence of the two formulations under fasting and fasting topical administration conditions.
Secondary Objective: To observe the safety of oral administration of the test formulation potassium chloride sustained-release capsules (0.75 g) and the reference formulation potassium chloride sustained-release capsules (750 mg) to healthy participants.
/ CompletedNot Applicable 氯化钾缓释胶囊（0.75g）在中国健康受试者中空腹及空腹果酱撒布给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性预试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence pilot study of potassium chloride sustained-release capsules (0.75 g) in Chinese healthy volunteers under fasting and jam-sprinkling conditions.
主要研究目的：选择Actavis Laboratories Fl Inc为持证商的氯化钾缓释胶囊（规格：750mg）为参比制剂，对浙江诺得药业有限公司生产，浙江众延医药科技有限公司提供的受试制剂氯化钾缓释胶囊（规格：0.75g）进行空腹及空腹果酱撒布给药人体生物等效性预试验，评估两制剂的药代动力学特征，为正式试验设计提供参考依据。
次要研究目的：观察健康志愿受试者口服受试制剂氯化钾缓释胶囊（规格：0.75g）和参比制剂氯化钾缓释胶囊（规格：750mg）的安全性。
[Translation] Primary Study Objective: To conduct a preliminary human bioequivalence study of potassium chloride sustained-release capsules (750 mg), manufactured by Actavis Laboratories FL Inc., as the reference preparation, and potassium chloride sustained-release capsules (0.75 g), manufactured by Zhejiang Nord Pharmaceutical Co., Ltd. and provided by Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd., using both fasting and jam-spray administration. This study evaluated the pharmacokinetic characteristics of the two preparations and provided a basis for the design of the formal study.
Secondary Study Objective: To observe the safety of oral administration of the test potassium chloride sustained-release capsules (0.75 g) and the reference potassium chloride sustained-release capsules (750 mg) in healthy volunteers.
100 Clinical Results associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
100 Deals associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Zhejiang Zhongyan Pharmaceutical Technology Co., Ltd
