Safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects.
Purpose: The objective of this study was to evaluate the safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole (PPZ) sodium injections following single and multiple intravenous doses in healthy Chinese subjects.Methods: The dosage groups were set as followed: 20 mg of single and multi...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 74; no. 3; pp. 257 - 266 |
|---|---|
| Autores principales: | , , , , , , , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Springer Nature
Mar2018
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=127943477&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 127943477 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Mar2018 vid: 74 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 127943477 127943477 127943477 10.1007/s00228-017-2372-6 127943477 ppf: 257 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects. aug: au: Jiao, Hui-Wen Sun, Lu-Ning Li, Yue-Qi Yu, Lei Zhang, Hong-Wen Wang, Mei-Feng Yu, Li-Yuan Yuan, Zi-Qing-Yun Xie, Li-Jun Chen, Juan Meng, Ling Zhang, Xue-Hui Wang, Yong-Qing affil: Research Division of Clinical Pharmacology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, 210029, Nanjing, People’s Republic of China sug: subj: Patient Safety Pantoprazole Sodium Pharmacokinetics Pantoprazole Sodium Pharmacodynamics Pantoprazole Sodium Administration and Dosage Chinese Persons Human Clinical Trials Administration, Intravenous Pantoprazole Sodium Blood Hydrogen-Ion Concentration Gastric Acid Drug Effects ab: Purpose: The objective of this study was to evaluate the safety, pharmacokinetics, and pharmacodynamics of S-(−)-pantoprazole (PPZ) sodium injections following single and multiple intravenous doses in healthy Chinese subjects.Methods: The dosage groups were set as followed: 20 mg of single and multiple intravenous administration of S-(−)-PPZ, 40 mg of single and multiple intravenous administration of S-(−)-PPZ or pantoprazole, and 80 mg of single dosage group of S-(−)-PPZ. Subjects were sampled for pharmacokinetic analysis and were monitored for 24-h intragastric pH prior to and 48-h intragastric pH after administration for the pharmacodynamic study. The pharmacokinetic and pharmacodynamic parameters were compared between S-(−)-PPZ and PPZ. Safety was evaluated on the basis of adverse events, vital signs, laboratory tests, and physical examination.Results: All adverse events were mild and of limited duration. Maximum plasma concentration and area under the concentration-time curve for S-(−)-PPZ were dose proportional over the range of 20–80 mg following a single intravenous administration. Elimination rate constant and half-life observed statistical difference from a single dose to multiple doses in 40 mg of S-(−)-PPZ groups. After administration of a single dose, the mean 24-h intragastric pH value was observed higher in 80-mg group than in 40- and 20-mg groups. Slightly increase of intragastric pH was found after a single dose of 40 mg S-(−)-PPZ than 40 mg PPZ; however, the differences were not statistically significant.Conclusions: Twice daily of 40 mg S-(−)-PPZ sodium injections is effective in achieving satisfying acid inhibition. Compared with plasma R-(+)-PPZ levels, most subjects presented more potent and prolonged suppression of gastric acid of S-(−)-PPZ, while a few subjects showed faster metabolic rate of S-(−)-PPZ in vivo. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|