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

Objective: To study the pharmacokinetics and comparative bioavailability of nefopam tablets (Acupan (R)). 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-infinity) 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 (C) 2011 S. Karger AG, Basel