Estimation of the area under the concentration-time curve of racemic lansoprazole by using limited plasma concentration of lansoprazole enantiomers.
OBJECTIVE: The purpose of this study was to identify the common time point that gives plasma concentrations of lansoprazole enantiomers that adequately reflect the AUC of racemic lansoprazole. METHODS: A randomized, double-blind, placebo-controlled, crossover study in three phases was conducted at i...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 64; no. 5; pp. 503 - 510 |
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| Autores principales: | , , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
Springer Nature
May2008
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| 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=105792092&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105792092 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: May2008 vid: 64 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 105792092 2009880446 10.1007/s00228-007-0455-5 NLM18224311 105792092 ppf: 503 ppct: 7 formats: fmt: @attributes: type: P tig: atl: Estimation of the area under the concentration-time curve of racemic lansoprazole by using limited plasma concentration of lansoprazole enantiomers. aug: au: Niioka T Miura M Uno T Yasui-Furukori N Hayakari M Tateishi T Suzuki T affil: Department of Pharmacy, Hirosaki University Hospital, Aomori, Japan. sug: subj: Proton Pump Inhibitors Pharmacokinetics Proton Pump Inhibitors Sulfur Compounds Pharmacokinetics Sulfur Compounds Adult Amines Pharmacodynamics Chemistry Clarithromycin Pharmacodynamics Crossover Design Double-Blind Studies Female Genotype Male Models, Biological Oxidoreductases Antagonists and Inhibitors Oxidoreductases Metabolism Pharmacokinetics Proton Pump Inhibitors Blood Sulfur Compounds Blood Time Human Adult: 19-44 years Female Male ab: OBJECTIVE: The purpose of this study was to identify the common time point that gives plasma concentrations of lansoprazole enantiomers that adequately reflect the AUC of racemic lansoprazole. METHODS: A randomized, double-blind, placebo-controlled, crossover study in three phases was conducted at intervals of 2 weeks. Eighteen healthy Japanese volunteers, including three CYP2C19 genotype groups, took a single 60-mg oral dose of lansoprazole after 6 days of pretreatment, with either clarithromycin (800 mg/day), fluvoxamine (50 mg/day), or a placebo. Multiple linear regression analysis was used to identify the most informative sampling times of (R)- and (S)-lansoprazole, using one to three samples to estimate the AUC(0-infinity) of racemic lansoprazole. RESULTS: The best R (2) in each prediction formula for the AUC of racemic lansoprazole using one, two, and three sampling points of (R)- and (S)-lansoprazole based on the data sets from all three pretreatment groups (n = 54) were 0.897, 0.930, and 0.929, respectively. The best prediction formula for the AUC of racemic lansoprazole, using the fewest sampling points of (R)- and (S)-lansoprazole, was [Formula: see text] (P < 0.001), where C(3h) is the plasma concentration 3 h after administration, G1 = 1 for the homozygous extensive metabolizer (EM) and 0 for the other genotypes, G2 = 1 for the heterozygous EM and 0 for the other genotypes. CONCLUSIONS: C(3h) monitoring of (R)- and (S)-lansoprazole is a useful time point to estimate the AUC of racemic lansoprazole. This method of plasma concentration monitoring at a few time points within 3 h might be more suitable for AUC estimation than CYP2C19 genotyping, particularly when lansoprazole is co-administered with CYP inhibitors. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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