Multiple-dose pharmacokinetics of ceftibuten after oral administration to healthy volunteers.
J Pharm Sci
; 83(9): 1236-40, 1994 Sep.
Article
em En
| MEDLINE
| ID: mdl-7830237
ABSTRACT
The pharmacokinetics of ceftibuten in plasma and urine were investigated after oral administration. Twelve healthy subjects were treated orally twice daily with 400 mg of the drug for 7 days; on day 8, the subjects received a last dose of 400 mg of ceftibuten. Ceftibuten and its metabolite, the trans isomer of ceftibuten, were assayed in plasma and urine by a specific HPLC method with UV detection. Ceftibuten was rapidly absorbed, as evidenced by the mean time to the maximum observed cis-ceftibuten concentration of 2.4 h. To describe the drug intake process, a Weibull model was used. For the metabolite, the mean time to maximum concentration in plasma was 3.25 h. Mean values for the terminal half-life in plasma were 2.17 h for cis-ceftibuten and 3.19 h for trans-ceftibuten. The overall elimination half-life, tmax, and total and renal clearances of cis-ceftibuten were invariant with respect to duration of dosing. The area under the plasma concentration versus time curve from 0 to infinity and the Cmax of this drug were significantly higher on day 8 than the values predicted from the elimination half-life computed on day 1 of treatment and the dosing interval. The pharmacokinetic parameters of trans-ceftibuten were invariant with respect to duration of dosing. Ceftibuten was well tolerated; there were no clinically significant adverse clinical events. The results from the present study indicate that the levels of cis-ceftibuten in plasma as well as in urine remain above the MICs for susceptible organisms over the dosing interval.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cefalosporinas
Tipo de estudo:
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Humans
/
Male
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
1994
Tipo de documento:
Article