Bioequivalence evaluation of two clarithromycin tablet formulations: A randomized,single-dose,open-label,two-treatment period cross over study in healthy male Pakistani volunteers

Objective: to conduct the bioequivalence study of commercially available two brands of clarithromycin tablets (500 mg) in healthy pakistani male volunteers. methodology: the study was performed using a randomized,open labeled,two treatment periods and cross over study design. healthy volunteers (n =12) were recruited following strict inclusion criteria. their blood samples were collected at various time intervals over a period of 24 hrs after oral administration of test and reference formulations of clarithromycin tablets (500 mg). a validated reversed-phase high performance liquid chromatographic method with ultraviolet detection (rp-hplc-uv) was used for the quantification of plasma concentrations of clarithromycin. various pharmacokinetic parameters were determined using non-compartmental analysis approach. results: the cmax,tmax,auc0−t and half-life (t1/2) values of clarithromycin from test formulation were 2.882 ±0.13 μg/ml,1.75 ±0.45 hr,11.33 ±0.68 μg.hr/ml and 2.84 ±0.17 hr,while for reference formulation these were 3.089 ±0.19 μg/ ml,1.83 ±0.39 hr,12.87 ±1.09 μg.hr/ml and 3.10 ±0.28 hr,respectively. the 90% confidence interval values of cmax,tmax,auc0-t and half life for test and reference formulations of clarithromycin were 0.89-0.98,0.80-1.14,0.84-0.93 and 0.88-0.95,respectively,which satisfied the acceptance ranges of who and fda bioequivalence guidelines i.e.,0.80-1.25. similarly,in-vitro evaluation studies were also performed for both test and reference formulations of clarithromycin as specified in the official monographs in usp-30. both formulations qualified all the in-vitro tests as per specifications in their respective monographs. the f1 and f2 values were also within the acceptance ranges for test and reference formulations. conclusion: the test and reference formulations of clarithromycin were bioequivalent. © 2017,postgraduate medical institute. all rights reserved.