Pharmacokinetic Evaluation of Two Brands of Linezolid Tablets in Healthy Human Volunteers
DOI:
https://doi.org/10.37285/ijpsn.2010.3.2.6Abstract
The aim of a randomized, balanced, two treatment, two-period, two-sequence, single-dose, crossover pilot bioavailability and bioequivalence study conducted in 12 healthy adult male volunteers under fasting conditions was to compare steady state pharmacokinetics of Linezolid 600mg tablets of Dr.Reddy’s Laboratories Ltd, and Zyvox ® (Linezolid) 600mg tablets of Pharmacia & Upjohn Company, USA. The subjects were dosed once during the study and the pre-dose blood samples were collected within 1 hr prior to dosing. The concentrations of Linezolid from the blood samples were quantified by validated HPLC method and pharmacokinetic parameters were computed. 90% Confidence intervals of reference Vs test for Cmax lower limit 87.23 and upper limit 109.24, AUC0-t lower limit 86.20 and upper limit 109.17, AUCO-α lower limit 85.48 and upper limit 111.54. Analysis of variance (ANOVA) did not show significant difference to these parameters. Based on the results obtained, both the formulations have exhibited the same rate and extent of absorption, indicating switch ability in clinical practice.
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Keywords:
Linezolid, single dose, pharmacokinetics, statistics
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References
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