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

To study the pharmacokinetics and comparative bioavailability of Nefopam tablets [Acupan[R]]. 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. 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 ngúh/ml and 307.53 +/- 8.99 ngúh/ml, respectively. The results showed that both formulations possessed almost the same relative bioavailability and pharmacokinetic parameters