Assayed A.Sallam
Jordan
Research Article
Bioequivalence of Two Oral Extended Release Formulations of Ciprofloxacin Tablets in HealthyMale Volunteers under Fed and Fasting Conditions
Author(s): Derar M. Omari, Dalia Johary, Isam I. Salem, Naji Najib and Assayed A.SallamDerar 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 c.. View More»
DOI:
10.4172/jbb.1000055