Pharmacokinetics and comparative bioavailability study of two clarithromycin suspensions following administration of a single oral dose to healthy volunteers.
The aim of the present study was to compare the pharmacokinetics and bioavailability of two commercial brands of clarithromycin (CAS 81103-11-9) suspensions in healthy male Iranian volunteers. In an open label, single-dose, randomized study with a crossover design an equivalent 500-mg clarithromycin suspension was given orally to each of 24 subjects as a single dose on two treatment days. The treatment periods were separated by a one-week washout period. Blood samples were drawn at different time points and the separated plasma was kept frozen at -20 degrees C for subsequent analysis. The plasma concentrations of the drug were analyzed by a rapid and sensitive HPLC method with UV detection. Mean maximum serum concentrations of 2256.5 +/- 590.1 ng/mL and 2840.2 +/- 717.5 ng/mL were obtained for the test and reference formulation, respectively. The AUC(0-infinity) of clarithromycin was on average 45008.7 +/- 10989.9 ng x h/mL for the test and 45221.3 +/- 2155.7 ng x h/mL for the reference formulation. The calculated 90% confidence intervals for the ratio of Cmax (81.98-94.26%), AUC(0)(t) (91.6-109.15%) and AUC(0)(infinity) (93.08-110.85%) values for the test and reference products were all within the 85-120% interval proposed by the FDA and EMEA. Therefore the clarithromycin suspension of the test and reference formulations are bioequivalent in terms of rate and extent of absorption.
Zakeri-Milani
Parvin
P
Department of Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, Iran.
Valizadeh
Hadi
H
Ghanbarzadeh
Saeed
S
Nemati
Mahboob
M
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D017291:Clarithromycin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006207:Half-Life; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D011500:Protein Synthesis Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions; D055815:Young Adult
D011500:Protein Synthesis Inhibitors; D013535:Suspensions; D017291:Clarithromycin