title: 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®).
  
  
  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.
  
  
  CONCLUSIONS
  The results showed that both formulations possessed almost the same relative bioavailability and pharmacokinetic parameters.
authors: Faculty of Pharmacy and Alternative Medicines, Islamia University of Bahawalpur, Bahawalpur, Pakistan.
authors: Mahmood
authors: M
authors: Ahmad
authors: Muhammad
authors: M
authors: Yaqoob
authors: Ghulam
authors: G
authors: Murtaza
mesh_terms: D000328:Adult; D000367:Age Factors; D018712:Analgesics, Non-Narcotic / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001681:Biological Assay; D001682:Biological Availability; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005215:Fasting; D006801:Humans; D008297:Male; D009340:Nefopam / Q000097:blood / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D009340:Nefopam