A crossover randomized bioequivalence study of two formulations of clarithromycin in healthy male volunteers

Abstract

A crossover-randomized bioequivalence study of two oral formulations of 500 mg clarithromycin tablet, an antibiotic, was carried out in 15 healthy male Bangladeshi volunteers. The test and reference formulations were CLARIN™ (Drug International Ltd, Bangladesh) and KLACID™ (Abbott Laboratories, USA), respectively. Each tablet was administered with 150 mL of water to subjects after overnight fasting on 2 treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24 hours. The plasma concentration of clarithromycin was estimated using a validated HPLC method. The pharmacokinetic parameters Cmax, Tmax, AUC0→24h, t1/2, and Kel were determined. The Cmax for test and reference drugs were 3.12 ± 0.88 and 3.37 ± 1.2 μg/mL (90% CI: 84.86-115.13%) respectively. The Tmax for test and reference drugs were 1.50 ± 0.32 and 1.40 ± 0.28 hours (90% CI: 90.66-109.33%) respectively. The mean AUC0→24h for test and reference drugs were 13.78 ± 5.02 and 16.40 ± 4.56 μg.hr/mL (90% CI: 88.17-111.82%) respectively. The relative bioavailability of text/reference drug was 84.02%. The mean t1/2 and kel for test drug were 2.96 hours and 0.2562 respectively whereas the values for reference drug were 3.37 hours and 0.2698 respectively. The 90% CI for the test and reference drugs were found within the acceptance range of 80-125%.