生物等效性和生物利用度杂志

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Comparative Bioavailability of Two Brands of Ofloxacin in Healthy Human Volunteers

Rajani Shakya, Manila Hada, Panna Thapa and R. N. Saha

The relative bioavailability and pharmacokinetics of a locally manufactured (Oquin) and reference (Zanocin) formulations of ofloxacin were compared . Each volunteer received a single dose of 200 mg ofloxacin tablet , test or reference with a 7 days washout period. Multiple blood samples were collected and plasma concentrations of ofloxacin were analyzed by high performance liquid chromatography technique. Following oral administration of both formulations, there was rapid and extensive oral absorption from gastrointestinal tract achieving maximum serum concentration within 2 hrs. The concentration-time pro fi l e g e n e r a t e d b y t h e t w o p r o d u c t s was found to be superimposable. Peak plasma concentration (C m a x ), area under the serum concentration-time curve (AUC 0 - 2 4 ), area under the serum concentration-time curve extrapolated to in fi n i t y ( A U C 0 - ∞ ) and serum elimination half- life (t ½ ) were 1.98 ± 0.213 and 1.82 ± 0.194 μ g/ml, 13.19 ± 1.45 and 12.56 ± 0.965 μ g.hr/ml, 13.86 ± 1.49 and 13.14 ± 0.959 μ g.hr/ml, 5.55 ± 1.37 and 5.55 ± 0.715 hr for Oquin and Zanocin, respectively. The result indicates that these two formulations have similar rate as well as extent of absorption. Hence these two products can be said to have comparable bioavailability.