Comparative bioavailability of ceftibuten in capsule and suspension forms

Clin Ther. 1996 Nov-Dec;18(6):1139-49. doi: 10.1016/s0149-2918(96)80068-3.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Biological Availability
  • Capsules
  • Ceftibuten
  • Cephalosporins / administration & dosage*
  • Cephalosporins / pharmacokinetics*
  • Chromatography, High Pressure Liquid
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Gram-Negative Bacterial Infections / blood
  • Gram-Negative Bacterial Infections / drug therapy
  • Gram-Positive Bacterial Infections / blood
  • Gram-Positive Bacterial Infections / drug therapy
  • Humans
  • Male
  • Reference Values
  • Suspensions
  • Therapeutic Equivalency

Substances

  • Capsules
  • Cephalosporins
  • Suspensions
  • Ceftibuten