Pharmacokinetic profile of SKP-1041, a modified release formulation of zaleplon.

Objectives: Two investigations aimed to define the pharmacokinetic profile of a modified-release preparation of zaleplon (SKP-1041).

Methods: Protocol SOM001 was a 5-way crossover, double-blind, randomized trial comparing three novel modified-release formulations of zaleplon 15 mg (SKP-1041A, SKP-1041B, SKP-1041C) to placebo and immediate-release zaleplon 10 mg. Protocol SOM002 was a randomized, crossover, open-label trial to compare the pharmacokinetics of SKP-1041B after day and night administration.