Bioequivalency of ranitidine tablets

J Clin Pharm Ther. 1989 Apr;14(2):111-7. doi: 10.1111/j.1365-2710.1989.tb00229.x.

Abstract

The bioavailability of two brands of ranitidine tablets was studied in 10 healthy volunteers. Formulation factors were compared by performing disintegration, dissolution and content uniformity tests. Plasma concentrations of ranitidine were measured using a sensitive and precise high pressure liquid chromatographic (HPLC) procedure. Pharmacokinetic parameters were determined for both formulations and included: Cmax, AUCt, AUC infinity, tmax, t1/2 and the terminal rate of elimination (k). Statistical analysis revealed that differences between the brands were not significant. The two formulations can be considered to be bioequivalent.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid
  • Humans
  • Male
  • Ranitidine / administration & dosage
  • Ranitidine / pharmacokinetics*
  • Solubility
  • Tablets
  • Therapeutic Equivalency

Substances

  • Tablets
  • Ranitidine