Relative bioavailability of zaleplon dispersible tablets in healthy human subjects

OBJECTIVE To study the relative bioavailability of zaleplon dispersible tablets in healthy human subjects. METHODS In a randomized crossover study, 20 healthy male volunteers were given a single oral dose of 20 mg zaleplon dispersible tablets or capsules. Zaleplon in plasma were determined by a RP-HPLC. RESULTS After administration of the dispersible tablets and capsules, the pharmacokinetic parameters were: C max ( 63.6± 14.7) and ( 61.9± 16.0) μg·L -1, T max ( 0.9± 0.4) and ( 1.0± 0.4) h, T 1/2 ( 0.96± 0.09) and ( 0.92± 0.10) h,AUC 0-6 h ( 156.4± 42.8) and ( 151.4± 42.8) μg·h·L -1, AUC 0-∞ were ( 160.9± 46.6) and ( 155.4± 46.0) μg·h·L -1, respectively. The relative bioavailability of dispersible tablets was ( 105.4± 20.0)%. CONCLUSION There is no significant difference in pharmacokinetic parameters between the two preparations. It is demonstrated that the two preparations are bioequivalent by two one-side t tests.