Pharmacokinetic study of a slow-release preparation of sodium valproate(KW-6066N). Single dose administration test and the effects of food on valproate absorption.

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  • 徐放性バルプロ酸ナトリウム製剤（ＫＷ‐６０６６Ｎ）の薬物動力学的検討　　単回投与試験およびバルプロ酸の吸収に対する食じの影響
  • Single Dose Administration Test and the Effects of Food on Valproate Absorption
  • 単回投与試験およびバルプロ酸の吸収に対する食餌の影響

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Comparative pharmacokinetic study of a new slow-releasing preparation of sodium valproate (KW-6066 N) was carried out in 8 healthy volunteers. When pharmacokinetic parameters were compared between this slow-releasing tablet and marketed valproate tablet (Depakene) after 600 mg single dose administration, there were difference in Vd, Lag time, Tmax and Cmax, but no difference was found in Kel and AUC between these two drugs. Both of these drugs were comparable to the extent of biavailability, but not comparable to the rate of bioavailability, demonstrating delayed absorption of the slowreleasing tablet. There were no effects of food on the slow-releasing tablet, but there were differences in absorption rate of marketed valproate tablet. When steady state serum levels after multiple dose administration of KW-6066 N were simulated, the diurnal fluctuation of serum concentratin was very a little in twice daily doses and slightly large in once daily doses. However the variations of concentrations in these administrations seemed to be permissible capacity from the viewpoint of expectation of therapeutic effects of KW-6066 N.

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