Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC

Pak J Pharm Sci. 2008 Jul;21(3):299-306.

Abstract

Pharmacokinetics and bioequivalence studies of two brands of ciprofloxacin 500 mg (Ciprofloxacin & Ciproxin) were evaluated in 14 healthy male volunteers after oral administration. The drug was analyzed in plasma samples by using HPLC. The peak plasma concentrations of (2.28+/-0.04 mg/L) and (1.9+/-0.02 mg/L) was attained in about 1.71 hours and 2.00 hours for both Test and Reference ciprofloxacin, respectively. The mean +/- SE values for total area under the curve (AUC) were 11.91+/-0.26 and 13.11+/-0.27 h.mg/L for both test and reference tablets respectively. This study indicated that all the differences in bioequivalence parameters for both ciprofloxacin formulations are statistically non-significant, hence both formulations are bioequivalent.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Infective Agents / administration & dosage
  • Anti-Infective Agents / blood
  • Anti-Infective Agents / pharmacology*
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid*
  • Ciprofloxacin / administration & dosage
  • Ciprofloxacin / blood
  • Ciprofloxacin / pharmacokinetics*
  • Cross-Over Studies
  • Humans
  • Male
  • Tablets
  • Therapeutic Equivalency

Substances

  • Anti-Infective Agents
  • Tablets
  • Ciprofloxacin