title: Human Bioequivalence Study of Clarithromycin from Two Tablet Formulations after Single Oral Administration.
abstract: OBJECTIVE
  The objective of this study was to compare the relative bioavailability and bioequivalence of a test (Claromycin®, GA Pharmaceuticals) and a reference (Klaricid®, Abbott) tablet containing 500mg clarithromycin in healthy volunteers under fasting conditions.
  
  
  METHODS
  This was a nonblinded, single-dose, randomised, two-period, crossover study in 16 healthy volunteers conducted under fasting conditions. Plasma samples were analysed for clarithromycin by a validated high performance liquid chromatography assay with electrochemical detection.
  
  
  RESULTS
  One volunteer did not receive the reference tablet. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios analysed for 16 participants were 84.2 to 111.6% (point estimate 97.3%) for the area under the plasma concentration-time curve for time zero to infinity (AUC0-∞), 82.2 to 117.6% (point estimate 98.3%) for time zero to time t (AUC0-t), and 74.4 to 142.9% (point estimate 103.1%) for peak plasma concentration (Cmax). No statistically significant differences were found between the formulations for the time to reach Cmax (tmax) and elimination half-life values. When the results were analysed for 15 participants, the 90% confidence intervals were 84.1 to 111.9% for AUC0-∞, 82.8 to 119.1% for AUC0-t, and 74.1 to 143.6% for (Cmax)
  
  
  CONCLUSIONS
  From the results of this study, it is concluded that the two tablet preparations of clarithromycin are bioequivalent in both the extent and the rate of absorption.
authors: Department of Pharmacy, School of Health Sciences, Aristotle University of Thessaloniki, 540 06, Thessaloniki, Greece. niopas@pharm.auth.gr.
authors: I
authors: I
authors: Niopas
authors: Analyses of Pharmaco-Chemical Products, American Farm School of Thessaloniki, Thessaloniki, Greece.
authors: A C
authors: AC
authors: Daftsios
authors: Analyses of Pharmaco-Chemical Products, American Farm School of Thessaloniki, Thessaloniki, Greece.
authors: N
authors: N
authors: Nikolaidis