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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date18 Oct 1979 |
评价5%米诺地尔泡沫剂在成年雄激素性脱发女性受试者中的有效性、安全性的多 中心、双盲、随机、安慰剂平行对照临床试验
[Translation] A multicenter, double-blind, randomized, placebo-controlled parallel clinical trial evaluating the efficacy and safety of 5% minoxidil foam in adult female subjects with androgenetic alopecia.
主要试验目的:以目标区域非毳毛计数(TAHC)为主要终点,评价 5%米诺地尔泡沫剂每日一次应用与安慰剂相比在女性雄激素性脱发受试者中的有效性; 次要试验目的:评价 5%米诺地尔泡沫剂每日一次应用与安慰剂相比在女性雄激素性脱发受试者中的有效性及安全性。
[Translation] Primary trial objective: To evaluate the efficacy of once-daily application of 5% minoxidil foam compared to placebo in female subjects with androgenetic alopecia, with target area non-vellus hair count (TAHC) as the primary endpoint; Secondary trial objective: To evaluate the efficacy and safety of once-daily application of 5% minoxidil foam compared to placebo in female subjects with androgenetic alopecia.
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.
100 Clinical Results associated with Shanxi Ante Bio-Pharmaceutical Co., Ltd.
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