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 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.
Medienart: |
Artikel |
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Erscheinungsjahr: |
1999 |
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Erschienen: |
1999 |
Enthalten in: |
Zur Gesamtaufnahme - volume:39 |
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Enthalten in: |
Journal of clinical pharmacology - 39(1999), 12 vom: 14. Dez., Seite 1283-9 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Karol, M D [VerfasserIn] |
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Anmerkungen: |
Date Completed 16.12.1999 Date Revised 26.08.2019 published: Print Citation Status MEDLINE |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM105162833 |
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100 | 1 | |a Karol, M D |e verfasserin |4 aut | |
245 | 1 | 0 | |a Lack of pharmacokinetic interaction between lansoprazole and intravenously administered phenytoin |
264 | 1 | |c 1999 | |
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500 | |a Date Completed 16.12.1999 | ||
500 | |a Date Revised 26.08.2019 | ||
500 | |a published: Print | ||
500 | |a Citation Status MEDLINE | ||
520 | |a 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 | ||
650 | 4 | |a Clinical Trial | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 7 | |a 2-Pyridinylmethylsulfinylbenzimidazoles |2 NLM | |
650 | 7 | |a Anti-Ulcer Agents |2 NLM | |
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