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Titolo:
Effect of cimetidine on the pharmacokinetics of oral gemifloxacin in healthy volunteers
Autore:
Allen, A; Bird, N; Dixon, R; Hickmott, F; Pay, V; Smith, A; Stahl, M;
Indirizzi:
GlaxoSmithKline Pharmaceut, Clin Pharmacol & Expt Med, Clin Pharmacokinet,Welwyn Garden City AL6 9AR, Herts, England GlaxoSmithKline Pharmaceut Welwyn Garden City Herts England AL6 9AR gland GlaxoSmithKline Pharmaceut, Clin Pharmacol & Expt Med, Harlow, Essex, England GlaxoSmithKline Pharmaceut Harlow Essex England , Harlow, Essex, England GlaxoSmithKline Pharmaceut, Clin Pharmacol Stat & Data Sci, Harlow, Essex,England GlaxoSmithKline Pharmaceut Harlow Essex England i, Harlow, Essex,England GlaxoSmithKline Pharmaceut, Drug Metab & Pharmacokinet, Welwyn Garden CityAL6 9AR, Herts, England GlaxoSmithKline Pharmaceut Welwyn Garden City Herts England AL6 9AR gland
Titolo Testata:
CLINICAL DRUG INVESTIGATION
fascicolo: 7, volume: 21, anno: 2001,
pagine: 519 - 526
SICI:
1173-2563(2001)21:7<519:EOCOTP>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
IN-VITRO; FLUORONAPHTHYRIDONE; LB20304; PLASMA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
19
Recensione:
Indirizzi per estratti:
Indirizzo: Allen, A GlaxoSmithKline Pharmaceut, Clin Pharmacol & Expt Med, Clin Pharmacokinet,Welwyn Garden City AL6 9AR, Herts, England GlaxoSmithKline Pharmaceut Welwyn Garden City Herts England AL6 9AR
Citazione:
A. Allen et al., "Effect of cimetidine on the pharmacokinetics of oral gemifloxacin in healthy volunteers", CLIN DRUG I, 21(7), 2001, pp. 519-526

Abstract

Objective: Cimetidine is a potent histamine H-2-receptor antagonist that is used for its ability to inhibit gastric acid secretion. This study investigated the effect of cimetidine on the pharmacokinetics of gemifloxacin, a novel fluoroquinolone antimicrobial agent. Study Participants and Design: This double-blind, randomised, placebo-controlled, two-period crossover study included 12 female and 10 male healthy volunteers who received a single oral dose of gemifloxacin 320mg orally on day 5 of 7 days of administration with either cimetidine 400mg or placebo four times daily. All 22 participants received both drug regimens in a randomised order, with at least a 7-day washout period between regimens. Plasma samples were collected up to 48 hours after drug administration of gemifloxacin and were assayed for gemifloxacin content in order to determine pharmacokinetic parameters. Urine samples were also collected up to 72 hours afterdrug administration and were assayed for gemifloxacin content. Results: Administration of cimetidine with gemifloxacin increased the areaunder the plasma concentration-time curve of gemifloxacin from time zero extrapolated to infinity (AUC(0-infinity)) by, on average. 10% [95% confidence interval (Cl) -4 to 25%] and increased the maximal plasma concentration (C-max), by, on average, 6% (95% Cl -6 to 20%) relative to results obtainedon coadministration of gemifloxacin with placebo. Renal clearance of gemifloxacin was decreased by 28% (95% CI -35 to 19%) when administered with cimetidine, presumably due to inhibition of organic cationic renal transport. This finding is unlikely to be of any clinical relevance. Gemifloxacin was well tolerated by all participants when coadministered with cimetidine or placebo. Conclusion: This study indicated that cimetidine had only minimal effects on the pharmacokinetics of gemifloxacin, which are unlikely to be of any clinical relevance. Gemifloxacin 320mg (as a single dose) was well tolerated by healthy volunteers when coadministered with cimetidine or placebo. The results of this study support the lack of need for dose adjustment of gemifloxacin when coadministered with cimetidine.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/09/20 alle ore 06:48:21