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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date18 Aug 2015 |
以安慰剂为对照评价罗西维林注射液缓解胃肠痉挛和胆道痉挛的安全性和有效性的随机、双盲、多中心临床研究
[Translation] A randomized, double-blind, multicenter clinical study to evaluate the safety and efficacy of roscevirine injection in relieving gastrointestinal spasm and biliary spasm with placebo as control
以安慰剂为对照评价罗西维林注射液缓解胃肠痉挛和胆道痉挛的安全性和有效性
[Translation] Evaluating the safety and efficacy of roscevirine injection in relieving gastrointestinal spasm and biliary spasm with placebo as control
[Translation] Pharmacokinetics of Roxivirine Injection in Humans
阐明健康受试者经单次和多次静脉给予罗西维林注射液后,药物在体内的动态变化规律(即药物吸收、分布、代谢和排泄的过程和特点);阐明本药在中国人体药代动力学特征,为罗西维林注射液进行下一步临床研究提供依据。
[Translation] To clarify the dynamic changes of the drug in the body (that is, the process and characteristics of drug absorption, distribution, metabolism and excretion) after single and multiple intravenous administration of Roxivirine injection to healthy subjects; The pharmacokinetic characteristics provide the basis for the further clinical research of roscevirine injection.
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