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 |
|---|---|
| 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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| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
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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 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
| 338 | |a Band |b nc |2 rdacarrier | ||
| 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 | |
| 650 | 7 | |a Anticonvulsants |2 NLM | |
| 650 | 7 | |a cytochrome P-450 CYP2C subfamily |2 NLM | |
| 650 | 7 | |a Lansoprazole |2 NLM | |
| 650 | 7 | |a 0K5C5T2QPG |2 NLM | |
| 650 | 7 | |a Phenytoin |2 NLM | |
| 650 | 7 | |a 6158TKW0C5 |2 NLM | |
| 650 | 7 | |a Cytochrome P-450 Enzyme System |2 NLM | |
| 650 | 7 | |a 9035-51-2 |2 NLM | |
| 650 | 7 | |a Omeprazole |2 NLM | |
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| 700 | 1 | |a Locke, C S |e verfasserin |4 aut | |
| 700 | 1 | |a Cavanaugh, J H |e verfasserin |4 aut | |
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| 952 | |d 39 |j 1999 |e 12 |b 14 |c 12 |h 1283-9 | ||