Comparative bioequivalence and pharmacokinetics of ciprofloxacin in healthy male subjects.
Author(s): Khan MK, Khan MF
Affiliation(s): Faculty of Pharmacy, Gomal University, Dera Ismail Khan, Pakistan.
Publication date & source: 2009-01, Pak J Pharm Sci., 22(1):1-7.
Publication type: Randomized Controlled Trial
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-alpha) 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.