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BIOEQUIVALENCE STUDY OF TWO ORAL FORMULATIONS OF CLARITHROMYCIN IN HUMAN MALE SUBJECTS M KHALID KHAN, MF KHAN, G MUSTAFA AND M SUALAH*  Faculty of P harmacy Gomal uni versity Dera is mail Khan Paki stan *Federal Urdu University of Arts, Science and Technology Gulshane!"#al $am%us, Karachi ABSTRACT To assess the bioequivalence of tablets formulations of Clarithromycin 500mg each of test and reference  products. A single post oral dose of each formulation was given to 14 male healthy volunteers. The study was conducted phase 1 open!label randomi"ed complete two! way crossover designed with # days wash out  period. The plasma concentration of Clarithromycin was quantified by validated microbiological assay method. The preci sion of the metho d was evalu ated using calibrated 14!hydro$ yCla rithr omyci n concentration was detected semi quantitatively as equivalent of Clarithromycin %ml. The pea& plasma concentrations of '(.)(*0.+0 ug%ml, and '(.(1*0.(5 ug%ml, was attained in about 1.4- hours and 1.4 hours for both test and reference Clarithromycin tablets respectively. The mean & / values for total area under the curve 'AC, were --.0#*4.0 and -0.1)*-.(5 h.mg%2 for both test and reference tablets respectively . This study indicated that the differences in all the bioequivalence parameters for test and reference Clarithromycin formulati ons are statistically non!signif icant3 hence both formulations are considered bioequivalent. Keywor! Clarithromycin area under the curve pea& plasma level bioequivalence studies. INTRODUCTION

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