Comparative bioavailability study of a generic naltrexone tablet preparation

Drug Dev Ind Pharm. 1999 Mar;25(3):353-6. doi: 10.1081/ddc-100102181.

Abstract

The bioavailability of a generic preparation of naltrexone (Narpan) was compared with the innovator product, Trexan. Twelve healthy volunteers participated in the study, conducted according to a completely randomized, two-way crossover design. The preparations were compared using the parameters area under the plasma concentration-time curve AUC0-infinity, peak plasma concentration Cmax, and time to reach peak plasma concentration Tmax. No statistically significant difference was observed between the logarithmic transformed AUC0-infinity and the logarithmically transformed Cmax values of the two preparations. Also, no statistically significant difference was observed between the untransformed Tmax values. In addition, the 90% confidence interval for the ratio of the logarithmic transformed AUC0-infinity values of Narpan over those of Trexan was found to lie between 0.87 and 1.01, while that of the logarithmic transformed Cmax values was between 0.94 and 1.23, both being within the bioequivalence limit of 0.80-1.25. The numerical values of the elimination half-life (t1/2) obtained with the two preparations were also not significantly different and were comparable to those reported in the literature.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Area Under Curve
  • Biological Availability
  • Cross-Over Studies
  • Drugs, Generic*
  • Humans
  • Male
  • Naltrexone / administration & dosage*
  • Naltrexone / blood
  • Naltrexone / pharmacokinetics*
  • Narcotic Antagonists / administration & dosage*
  • Narcotic Antagonists / blood
  • Narcotic Antagonists / pharmacokinetics*

Substances

  • Drugs, Generic
  • Narcotic Antagonists
  • Naltrexone