Study of the bioequivalence of zaleplon tablets in healthy volunteers

Objective: To study the bioequivalence of zaleplon tablets in healthy volunteers. Methods:The randomized crossover and self-control study was conducted in 20 healthy volunteers. They were treated with a single oral dose of 10 mg zaleplon tablets or a single oral dose of control drug (zaleplon capsules) and the blood drug concentrations were measured by HPLC equipped with a fluorescence detector. Results: The mean Cmax was (35. 01±9. 30)μg·L-1 for zaleplon tablets and (34.63±12.75) μg·L-1 for control;mean Tmax was (0.72±0.40)h for zaleplon tablets and (0.73±0. 30) h for control; mean t1/2 was (1. 04±0.21) h for zaleplon tablets and (1. 09±0.39) h for control; AUC0-t was (75.31±26.35)μg·h·L-1 for zaleplon tablets and (74. 54±37.13)μg·h·L-1 for con- trol. The relative bioavailability of zaleplon tablets was (105. 94±17. 69) % and no significant differ-ences between these pharmacokinetic parameters were observed. Conclusion: The bioavailability of zaleplon tablets is equivalent to that of control drug (zaleplon capsule).