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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Canada |
First Approval Date01 Jan 1985 |
维生素D口服溶液在维生素D缺乏人群的安全性、耐受性及药代动力学研究
[Translation] Safety, tolerability and pharmacokinetics of vitamin D oral solution in vitamin D-deficient populations
主要研究目的:评价维生素D缺乏人群单次空腹口服维生素D口服溶液的安全性和耐受性。
次要研究目的:评价维生素D缺乏人群单次空腹口服维生素D口服溶液的药代动力学特征。
[Translation] Primary study objective: To evaluate the safety and tolerability of a single fasting oral dose of vitamin D oral solution in vitamin D-deficient individuals.
Secondary study objective: To evaluate the pharmacokinetic profile of a single fasting oral dose of vitamin D oral solution in vitamin D-deficient individuals.
/ CompletedNot Applicable [Translation] Colchicine tablets human bioequivalence study
主要目的:本试验旨在研究单次空腹和餐后口服厦门紫旭医药科技有限公司研制、广东安诺药业股份有限公司生产的秋水仙碱片(0.5 mg)的药代动力学特征;以TAKATA SEIYAKUCO.,Ltd生产的秋水仙碱片(Colchicine®,0.5 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] Main objective: This study aimed to investigate the pharmacokinetic characteristics of colchicine tablets (0.5 mg) developed by Xiamen Zixu Pharmaceutical Technology Co., Ltd. and manufactured by Guangdong Anno Pharmaceutical Co., Ltd., after a single fasting and postprandial oral administration. Using colchicine tablets (Colchicine®, 0.5 mg) manufactured by TAKATA SEIYAKU CO., Ltd. as a reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.
/ Not yet recruitingPhase 3 评估维生素D口服溶液在维生素D缺乏试验参与者中的有效性和安全性的多中心、随机、双盲、安慰剂、平行对照的Ⅲ期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial evaluating the efficacy and safety of oral vitamin D solution in participants of a vitamin D deficiency trial.
主要目的:评价维生素D口服溶液在维生素D缺乏试验参与者中的有效性。
次要目的:
1、以其他疗效终点评价维生素D口服溶液在维生素D缺乏试验参与者中的有效性。
2、评价维生素D 口服溶液在维生素D 缺乏试验参与者中的安全性。
[Translation] Primary objective: To evaluate the efficacy of oral vitamin D solution in participants of a vitamin D deficiency trial.
Secondary objectives:
1. To evaluate the efficacy of oral vitamin D solution in participants of a vitamin D deficiency trial using other efficacy endpoints.
2. To evaluate the safety of oral vitamin D solution in participants of a vitamin D deficiency trial.
100 Clinical Results associated with Xiamen Zixu Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Xiamen Zixu Pharmaceutical Technology Co., Ltd.
100 Deals associated with Xiamen Zixu Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Xiamen Zixu Pharmaceutical Technology Co., Ltd.