/ CompletedNot Applicable [Translation] Study on the bioequivalence of nicergoline tablets in healthy volunteers
主要研究目的:研究空腹及餐后给药条件下,山东方明药业集团股份有限公司生产的尼麦角林片(10mg)与Upjohn EESV持证的尼麦角林片(10mg,商品名:SERMION)在中国健康受试者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:研究山东方明药业集团股份有限公司生产的尼麦角林片(10mg)与Upjohn EESV持证的尼麦角林片(10mg,商品名:SERMION)在中国健康受试者中的安全性。
[Translation] Primary study objective: To study the pharmacokinetics of nicergoline tablets (10 mg) produced by Shandong Fangming Pharmaceutical Group Co., Ltd. and nicergoline tablets (10 mg, trade name: SERMION) approved by Upjohn EESV in healthy Chinese subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions.
Secondary study objective: To study the safety of nicergoline tablets (10 mg) produced by Shandong Fangming Pharmaceutical Group Co., Ltd. and nicergoline tablets (10 mg, trade name: SERMION) approved by Upjohn EESV in healthy Chinese subjects.
/ CompletedNot Applicable 单硝酸异山梨酯片在中国健康受试者中单次口服给药的一项随机、开放、双周期、交叉生物等效性试验
[Translation] A randomized, open-label, two-period, crossover bioequivalence study of a single oral dose of isosorbide mononitrate tablets in healthy Chinese subjects
主要目的:观察单硝酸异山梨酯片在中国健康受试者中单次(空腹/餐后)口服给药后的单硝酸异山梨酯在体内动力学过程,估算相应的药代动力学参数,与参比制剂进行生物等效性评价。
次要目的:观察受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective: To observe the in vivo kinetics of isosorbide mononitrate tablets after a single (fasting/postprandial) oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and conduct bioequivalence evaluation with the reference preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy humans.
/ SuspendedNot Applicable 氟康唑胶囊在中国健康志愿者中进行的人体生物等效性试验
[Translation] Bioequivalence study of fluconazole capsules in healthy Chinese volunteers
观察中国健康志愿者在空腹/餐后状态下单次口服受试制剂氟康唑胶囊和参比制剂氟康唑胶囊后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
[Translation] To observe the pharmacokinetic characteristics of the test preparation fluconazole capsules and the reference preparation fluconazole capsules after a single oral administration in Chinese healthy volunteers under fasting/fed state, and to evaluate the bioequivalence of the two preparations under fasting/fed state.
100 Clinical Results associated with Shandong Fangming Pharmaceutical Stock Co. Ltd.
0 Patents (Medical) associated with Shandong Fangming Pharmaceutical Stock Co. Ltd.
100 Deals associated with Shandong Fangming Pharmaceutical Stock Co. Ltd.
100 Translational Medicine associated with Shandong Fangming Pharmaceutical Stock Co. Ltd.