Comparative bioavailability of ceftibuten in capsule and suspension forms.
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.
Lin
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CC
Department of Drug Metabolism and Pharmacokinetics, Schering-Plough Research Institute, Kenilworth, New Jersey, USA.
Affrime
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Radwanski
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E
Lim
J
J
Colucci
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R
Cayen
M N
MN
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002214:Capsules; D000077722:Ceftibuten; D002511:Cephalosporins / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D016905:Gram-Negative Bacterial Infections / Q000097:blood / Q000188:drug therapy; D016908:Gram-Positive Bacterial Infections / Q000097:blood / Q000188:drug therapy; D006801:Humans; D008297:Male; D012016:Reference Values; D013535:Suspensions; D013810:Therapeutic Equivalency
D002214:Capsules; D002511:Cephalosporins; D013535:Suspensions; D000077722:Ceftibuten