Journal of Bioequivalence & Bioavailability

Nunez DA

Publications

• Research Article
  Comparison of Two Formulations of Sodium Divalproate Plasma Concentrations after a Single 500 mg Oral Dose in Healthy Subjects, and Stochastic Sub-analysis of the Individual “ Clinical Perceptible ” Levels
  Author(s): Nunez DA, Schiaffino S and Roldán EJANunez DA, Schiaffino S and Roldán EJA
  
  A new generic formula containing 500 mg of sodium divalproate in enteric releasing coated tablets was compared to the reference product in a pharmacokinetic, randomized, cross-over 2×2 study performed in 24 healthy adult males. After administering a single dose, it was demonstrated that the maximum plasma concentration of valproic acid varies within the 98.4-113.0 range for 90% CI (test/reference); and the area under the curve of plasma levels over the 24 h period following the intake varies within the 91.1-99.5 range; therefore, it can be seen that both parameters are within the range of acceptance for the interchangeability of the products. Individual results show the typical inter- subject and inter -treatment variations of divalproate. Since the latter have an impact on the prescription decision, results are sub-analyzed considering a plasma threshold of valproic acid as eff.. View More»
  DOI: 10.4172/jbb.1000158

  Abstract PDF