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-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.
Khan
Muhammad Khalid
MK
Faculty of Pharmacy, Gomal University, Dera Ismail Khan, Pakistan.
Khan
Muhammad Farid
MF
D000284:Administration, Oral; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D013293:Enterococcus faecalis / Q000187:drug effects / Q000254:growth & development; D006207:Half-Life; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
D000890:Anti-Infective Agents; D013607:Tablets; D002939:Ciprofloxacin