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MechanismBcr-Abl inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
硫酸美迪替尼片在初治慢性髓系白血病慢性期受试者中单次给药剂量递增Ⅰ期临床试验
[Translation] Phase I clinical trial of single-dose escalation of Meditinib sulfate tablets in subjects with chronic phase chronic myeloid leukemia who were previously untreated
本研究的主要目的为研究初治慢性髓系白血病慢性期受试者单次口服硫酸美迪替尼片的耐受性和安全性;次要目的为考察初治慢性髓系白血病慢性期受试者单次口服硫酸美迪替尼片的人体药代动力学特征。
[Translation] The main purpose of this study is to investigate the tolerability and safety of a single oral administration of Meditinib sulfate tablets in subjects with newly diagnosed chronic myeloid leukemia in the chronic phase; the secondary purpose is to investigate the human pharmacokinetic characteristics of a single oral administration of Meditinib sulfate tablets in subjects with newly diagnosed chronic myeloid leukemia in the chronic phase.
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