Lack of Pharmacokinetic Interaction between Lansoprazole and Intravenously Administered Phenytoin

The objective of this randomized, double‐blind, two‐period crossover study was to investigate whether concomitant steady‐state lansoprazole influences the pharmacokinetics of CYP2C9 substrates using single intravenously dosed phenytoin as a model substrate. In addition, the safety of concomitant adm...

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Bibliographic Details
Published in:Journal of clinical pharmacology 1999-12, Vol.39 (12), p.1283-1289
Main Authors: Karol, Michael D., Locke, Charles S., Cavanaugh, John H.
Format: Article
Language:English
Subjects:
2-Pyridinylmethylsulfinylbenzimidazoles
Adult
Anti-Ulcer Agents - adverse effects
Anti-Ulcer Agents - pharmacokinetics
Anti-Ulcer Agents - pharmacology
Anticonvulsants - adverse effects
Anticonvulsants - pharmacokinetics
Anticonvulsants - pharmacology
Biological and medical sciences
Cross-Over Studies
Cytochrome P-450 Enzyme System - metabolism
Digestive system
Double-Blind Method
Drug Interactions
Humans
Injections, Intravenous
Lansoprazole
Male
Medical sciences
Metabolic Clearance Rate
Omeprazole - adverse effects
Omeprazole - analogs & derivatives
Omeprazole - pharmacokinetics
Omeprazole - pharmacology
Pharmacology. Drug treatments
Phenytoin - adverse effects
Phenytoin - pharmacokinetics
Phenytoin - pharmacology
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Summary:The objective of this randomized, double‐blind, two‐period crossover study was to investigate whether concomitant steady‐state lansoprazole influences the pharmacokinetics of CYP2C9 substrates using single intravenously dosed phenytoin as a model substrate. In addition, the safety of concomitant administration of these two drugs was evaluated. Twelve healthy, nonsmoking, adult male subjects received 60 mg lansoprazole or placebo once daily for 9 days during each study period. On the morning of day 7, each subject received a single 250 mg intravenous phenytoin dose. There were no statistically significant differences between the two regimens for mean phenytoin Cmax or tmax. There was a minor (< 3%) but statistically significant difference between the two regimens for phenytoin AUC resulting from a very low intrasubject coefficient of variation (2.3%). The treatment and control mean plasma concentration phenytoin profiles were virtually super‐imposable. In conclusion, concomitant multidose lansoprazole administration is unlikely to have any clinically significant effect on the pharmacokinetics of CYP2C9 substrates in general or intravenous phenytoin specifically.
ISSN:0091-2700
1552-4604
DOI:10.1177/00912709922011971