生物等效性和生物利用度杂志

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Bioequivalence of Two Oral Extended Release Formulations of Ciprofloxacin Tablets in HealthyMale Volunteers under Fed and Fasting Conditions

Derar M. Omari, Dalia Johary, Isam I. Salem, Naji Najib and Assayed A.Sallam

The bioavailability of a single dose of ciprofloxacin 1000 mg Extended release (XR) tablets manufactured by a Jordanian manufacturer (Hikma PLC), was compared with a reference ciprofloxacin 1000 mg XR tablets (Cipro® XR, Bayer-health care, Germany) in two different studies (under fasting and fed conditions). In each study, 28 healthy, male, Jordanian volunteers were enrolled. However, only 25 subjects in fasting study and 23 subjects in fed study completed the crossover. Each study was designed as single-center, open-label, randomized, single- dose, two-way crossover study. Nineteen blood samples were taken during 24hrs. Samples were frozen and kept until time of analysis. Ciprofloxacin concentrations in subjects’ plasma were determined by using a validated HPLC fluorescence technique. Confidence intervals (90%) for the peak plasma concentration (C max ) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed Test/Reference ratio using standard non-compartmental method and ANOVA statistics. The 90% CI result in fasting study for C max was 88.87 (82.17 - 96.10)% and for AUC0-t was 87.60 (80.38-95.46)%. In fed study the results were 102.09 (92.77-112.34)% and 104.06 (100.01-108.27)% for Cmax and AUC0-t, respectively. In conclusion, it is evident that the 90% CI for the primary pharmacokinetics parameters was within the bioequivalence acceptable boundaries of 80-125%, while for AUC0-t, and 75.-133% for C max . Therefore, it was concluded that both products were bioequivalent.