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Drug Highest PhasePhase 2 |
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MechanismPotassium channel blockers |
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Drug Highest PhaseIND Approval |
First Approval Ctry. / Loc.- |
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/ Not yet recruitingPhase 2 评价XC2309片治疗十二指肠溃疡的有效性和安全性的多中心、随机、双盲、阳性药对照的Ⅱ期临床研究
[Translation] A multicenter, randomized, double-blind, positive-controlled phase II clinical study to evaluate the efficacy and safety of XC2309 tablets in the treatment of duodenal ulcers
以兰索拉唑肠溶胶囊为对照,探索XC2309片不同剂量给药方案治疗十二指肠溃疡的有效性和安全性。
[Translation] Using lansoprazole enteric-coated capsules as a control, the efficacy and safety of different dosage regimens of XC2309 tablets in the treatment of duodenal ulcer were explored.
评价XC2309 片在健康受试者中的安全性、耐受性、药代动力学特征的单次、多次给药剂量递增及食物对PK 影响的I 期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics of XC2309 tablets in healthy subjects with single and multiple dose escalation and the effect of food on PK
评价健康受试者单次及多次服用XC2309 片后的安全性、耐受性、药代动力学特征;评价健康受试者空腹及餐后状态下服用XC2309 片的药代动力学特征,评价食物对药代动力学特征的影响;评价健康受试者单次及多次服用XC2309 片的药效学特征,为后期临床研究的剂量选择提供依据;探索鉴定健康受试者单次服用XC2309 片后人体内的主要代谢产物。
[Translation] To evaluate the safety, tolerability, and pharmacokinetic characteristics of XC2309 tablets after single and multiple administration in healthy subjects; to evaluate the pharmacokinetic characteristics of XC2309 tablets in healthy subjects in the fasting and postprandial states, and to evaluate the effect of food on the pharmacokinetic characteristics; to evaluate the pharmacodynamic characteristics of XC2309 tablets after single and multiple administration in healthy subjects, and to provide a basis for dose selection in later clinical studies; to explore and identify the main metabolites in the human body after a single administration of XC2309 tablets in healthy subjects.
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