COMPARATIVE BIOEQUIVALENCE AND PHARMACOKINETICS OF CIPROFLOXACIN IN HEALTHY MALE SUBJECTS

Pharmacokinetics and bioequivalence studies of two ciprofloxacin tablet brands (trial batch of ciprofloxacin(Test) Reference ) were conducted in 14 healthy male volunteers after oral administration. Each brand (test and reference) consisted of 500 mg of ciprofloxacin. The drug was analyzed in plasma samples with a microbiological assay using Streptococcus faecalis as test organism. The elimination half-life of 3.00 ± 0.21 and 3.28±0.11 h was calculated for both brands. The peak plasma concentrations of (3.59±0.26 ug/mL) and (3.34±1.20 ug/mL) was attained in about 1.48±0.11 hour and 1.47±0.05 for both Test and Reference ciprofloxacin respectively. The mean ± SE values for total area under the curve (AUC O-∞) were 26.15 ±1.35, and 24.95±0.93 hmg/1 for both test and reference tablets respectively. The mean ± SE values of clearance were 24.83±1.63 and 24.73±1.11 1/h for both formulations respectively. The ratio of elimination rate constant Kel [l/h] was 1.14 percent difference between the test and reference tablets and likewise, half-life (t1/2β) expressed in hours showed the ratio of 0.91 percent. This study indicated that all the pharmacokinetic and bioequivalence parameters for both ciprofloxacin formulations are statistically non-significant, hence both formulations are bioequivalent.