Comparative bioequivalence and pharmacokinetics of ciprofloxacin in healthy male subjects

ABSTRACT

Pharmacokinetics and bioequivalence studies of two ciprofloxacin tablet brands [trial batch of ciprofloxacin [Test] and 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-infinity] 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 [t1/2beta] 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