title: Pharmacokinetics, Pharmacodynamics and Safety of Multiple-Infusion Ilaprazole in Healthy Chinese Subjects.
abstract: OBJECTIVE
  Ilaprazole is a novel proton pump inhibitor that provides effective and long lasting inhibition of intragastric acid secretion. The objectives of this study were to investigate the pharmacokinetics, pharmacodynamics, and safety of intravenous ilaprazole after multiple administrations in healthy Chinese subjects.
  
  
  METHODS
  This was an open-label and multiple-dose clinical study. Ten healthy Chinese subjects received 10 mg ilaprazole infusion once daily for 5 days. Helicobacter pylori status was examined. Blood samples were collected and intragastric pH was recorded for 24 h. Safety was assessed throughout the study.
  
  
  RESULTS
  There was no accumulation after multiple administrations. The mean steady-state half-life and clearance were comparable to those following single administration. Ilaprazole provided sustainable and significant intragastric pH control in terms of percentage time at pH >4, pH >6 within 24 h and mean 24-h pH values. The pH value within 24 h was affected by Helicobacter pylori infection in subjects with continuous infusion. Intravenous ilaprazole was safe and there were no serious adverse events.
  
  
  CONCLUSIONS
  Intravenous ilaprazole provided stable pharmacokinetics and pharmacodynamics at a dose of 10 mg once daily for 5 days, and was well tolerated in healthy subjects.
authors.affiliation: Clinical Pharmacology Research Center, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
authors.forename: Hongyun
authors.initials: H
authors.lastname: Wang
authors.affiliation: Clinical Pharmacology Research Center, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
authors.forename: Liwei
authors.initials: L
authors.lastname: Lang
authors.affiliation: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Ou
authors.affiliation: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China.
authors.forename: Ruihua
authors.initials: R
authors.lastname: Shi
authors.affiliation: Livzon Pharmaceutical Co., Ltd., Zhuhai, Guangdong, 519020, China.
authors.forename: Haitang
authors.initials: H
authors.lastname: Hu
authors.affiliation: Clinical Pharmacology Research Center, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
authors.forename: Pei
authors.initials: P
authors.lastname: Hu
authors.affiliation: Clinical Pharmacology Research Center, Peking Union Medical College Hospital, No. 1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China. jiangjipumch@sohu.com.
authors.forename: Ji
authors.initials: J
authors.lastname: Jiang
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D000328:Adult; D044466:Asian People; D004305:Dose-Response Relationship, Drug; D005260:Female; D005745:Gastric Acidity Determination; D006207:Half-Life; D064368:Healthy Volunteers; D016481:Helicobacter Infections / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D008297:Male; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D013270:Stomach / Q000382:microbiology; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; C119615:ilaprazole