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Comparative bioavailability of ceftibuten in capsule and suspension forms.

Abstract：

:The comparative bioavailability of ceftibuten, a new third-generation cephalosporin antibiotic given orally once daily, in capsule and suspension dosage forms, was assessed in healthy male subjects. In three separate studies, subjects received either a 400-mg dose as a suspension or one laboratory-batch, 400-mg capsule; one laboratory-batch, 400-mg capsule or two laboratory-batch, 200-mg capsules; or one production-batch, 400-mg capsule or two laboratory-batch, 200-mg capsules. Plasma samples were assayed for ceftibuten using high-performance liquid chromatography, and the data were assessed using pharmacokinetic and statistical methods. Confidence intervals for the maximum plasma concentration and the area under the plasma concentration-time curve extrapolated to infinity were within 80% to 125% of guidelines, demonstrating the bioequivalence of the two treatments within each of the three studies. One 400-mg capsule (laboratory or production batch) was bioequivalent to two 200-mg capsules used in a clinical efficacy trial; the 400-mg suspension was bioequivalent to a 400-mg capsule (laboratory batch). Thus we concluded that the capsule and the suspension dosage forms were bioequivalent.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Lin CC,Affrime M,Radwanski E,Lim J,Colucci R,Cayen MN

doi

10.1016/s0149-2918(96)80068-3

subject

Has Abstract

pub_date

1996-11-01 00:00:00

pages

1139-49

issue

6

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(96)80068-3

journal_volume

18

pub_type

临床试验,杂志文章,随机对照试验

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