Bioequivalence of ciprofloxacin tablets in healthy volunteers

Aim: To study the relative bioequivalence of two domestic ciprofloxacin tablets. Methods: The randomized and crossover study was conducted in 18 healthy volunteers. After a single dose of the drugs, their plasma drug concentration was determined using HPLC. Results: Both the two domestic ciprofloxacin tablets fit to one compartment model. The main pharmacokinetics parameters of the tested and reference ciprofloxacin were as followings: Cmax: (2.503 ± 0.394) and (2.706 ± 0.579) mg · L-1; T max: (1.343 ± 0.402) and (1.075 ± 0.379) h; T 1/2: (4.174 ± 1.201) and (3.826 ± 1.005) h; AUC 0-tn: (10.528 ± 2.204) and (10.643 ± 1.922) mg · L-1 · h; AUC0-∞; (11.409 ± 2.139) and (11.558 ± 2.160) mg · L-1 · h; F0-tn and F0-∞ was (100.245 ± 18.447)% and (100.470 ± 20.108)%, respectively. Conclusion: The tested and reference formulations are bioeqivalent.