Study of pharmacokinetics and comparative bioavailability of nefopam 30 mg tablets in twelve fasting healthy Pakistani male young subjects: Single-dose, randomized, two-period, two-treatment and two-way cross-over design

Abstract

Objective: To study the pharmacokinetics and comparative bioavailability of nefopam tablets (Acupan®). Subjects and Methods: Experimentation of this study was based on a single-dose, two-sequence, cross-over randomized design using 12 fasting healthy Pakistani male young subjects. This validated LC/MS method was applied to a pharmacokinetic and bioavailability study in 12 fasting healthy Pakistani male subjects from the blood samples taken up to 24 h after an oral dose of one tablet of 30 mg nefopam in a double-blind, randomized, cross-over design. Results: The mean maximum plasma concentration (C max) for the reference formulation was 60.71 ± 2.36 ng/ml (± SEM) and for test formulation 60.46 ± 1.30 ng/ml (± SEM). The mean time to reach maximum plasma concentration (T max) values of reference and test formulations was 1.63 ± 0.13 h (± SEM) and 1.83 ± 0.07 h (± SEM), respectively. The mean ± SEM values of AUC 0-∞ for the reference and test formulations were 293.01 ± 16.09 ng·h/ml and 307.53 ± 8.99 ng·h/ml, respectively. Conclusion: The results showed that both formulations possessed almost the same relative bioavailability and pharmacokinetic parameters. Copyright © 2011 S. Karger AG.