【摘 要】
:
CPRC1 is a novel investigated proton pump inhibitor, which shows dramaticsuccess in the management of acid-related disorders.Now this drug is being developed in Phase Ⅱ study in China.In this paper fo
【机 构】
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Clinical Pharmacology Research Center, Peking Union Medical College Hospital,Chinese Academy of Medi
【出 处】
:
2015年第一届药代动力学朝阳论坛
论文部分内容阅读
CPRC1 is a novel investigated proton pump inhibitor, which shows dramaticsuccess in the management of acid-related disorders.Now this drug is being developed in Phase Ⅱ study in China.In this paper for the first time, a population pharmacokinetic (PopPK) model was developed to describe the PK characters of CPRC1 in patients with duodenal ulcer after receiving 20 mg CPRC1 intravenously.Plasma samples were collected and concentrations of CPRC1 were detected by a validated UPLC-MS/MS method.The PopPK model was developed using Phoenix NLME 1.2 with a non-linear mixed-effect model, and the following covariates were tested: weight, height, age, gender, alanine aminotransferase (ALT), aspartate aminotransferase (AST),total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), creatinine (CR) and genotype of CYP2C19.Covariate effects on parameters describing the pharmacokinetics relationship were screened using stepwise forward inclusion/backward elimination.
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