评价 5%米诺地尔泡沫剂和 ROGAINE®(5%米诺地尔泡沫剂)在成年雄激素性脱发男性受试者中疗效的等效性、安全性的多中心、双盲、随机、对照临床试验
[Translation] A multicenter, double-blind, randomized, controlled clinical trial to evaluate the equivalence and safety of 5% minoxidil foam and ROGAINE® (5% minoxidil foam) in adult male subjects with androgenetic alopecia
主要试验目的:评估成年雄激素性脱发(AGA)男性受试者使用5%米诺地尔泡沫剂与使用 ROGAINE®(5%米诺地尔泡沫剂)治疗的临床疗效等效性。
次要试验目的:比较试验药物和对照药物在成年雄激素性脱发男性受试者中的安全性。
[Translation] Primary study objective: To evaluate the clinical efficacy equivalence of 5% minoxidil foam and ROGAINE® (5% minoxidil foam) in adult male subjects with androgenetic alopecia (AGA).
Secondary study objective: To compare the safety of the test drug and the control drug in adult male subjects with androgenetic alopecia.
/ CompletedNot Applicable 空腹及餐后口服马来酸曲美布汀片在中国成年健康志愿者中的人体生物等效性研究
[Translation] Study on the bioequivalence of fasting and fed oral trimebutine maleate tablets in Chinese healthy adult volunteers
在健康受试者体内,分别在空腹和餐后条件下,以田边三菱制药株式会社持有的马来酸曲美布汀片(商品名:Cerekinon®;规格:100 mg)为参比制剂,研究山西振东安欣生物制药有限公司研制的马来酸曲美布汀片(规格:100 mg;受试制剂)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。次要试验目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] In healthy subjects, the pharmacokinetics of trimebutine maleate tablets (specification: 100 mg; test preparation) developed by Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd. were studied under fasting and postprandial conditions, using trimebutine maleate tablets (trade name: Cerekinon®; specification: 100 mg) owned by Mitsubishi Tanabe Pharma Corporation as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. Secondary study objective: To observe the safety of oral administration of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 含胶体果胶铋胶囊四联疗法根除幽门螺杆菌(Hp)有效性和安全性的多中心、随机、双盲双模拟、阳性对照临床研究
[Translation] A multicenter, randomized, double-blind, double-dummy, positive-controlled clinical study on the efficacy and safety of quadruple therapy containing colloidal pectin bismuth capsules in eradicating Helicobacter pylori (Hp).
采用含枸橼酸铋钾片四联疗法作为对照,评价含胶体果胶铋胶囊四联疗法根除Hp的有效性及安全性。
[Translation] The efficacy and safety of quadruple therapy containing colloidal bismuth pectin capsules in eradicating Hp were evaluated by using quadruple therapy containing potassium citrate bismuth tablets as a control.
100 Clinical Results associated with Shanxi Ante Bio-Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanxi Ante Bio-Pharmaceutical Co., Ltd.
100 Deals associated with Shanxi Ante Bio-Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanxi Ante Bio-Pharmaceutical Co., Ltd.