2002•The Chinese Journal of Clinical PharmacologyRequires access

Relative Bioavailability of Zaleplon Capsule in Healthy Volunteers

Yang Jing

Abstract

OBJECTIVE:The pharmacokinetics and bioavailability of test capsulewere compared with reference tablet.METHODS:A single oral dose l0mg zaleplonof reference (tablet) or test (capsule) drugs was given to healthy male volunteersaccording to an open randomized crossover study.The concentrations in plasmawere determined by HPLC method.RESULTS:The main pharmacokinetics parametersof zaleplon were:tmaxl.04±0.35h and l.l0±0.45h,Cmax 26.06±9.l4μg.L-1 and27.39±7.5lμg.L-1,t(1/2ke)l.33±0.26h and l.34±0.22h,AUC0-8 83.39±37.35μg.h.L-1and 87.44±35.25μg.h.L-1for capsule and tablet respectively.The bioavailability ofeffervescent capsule to tablet was 94.40%±ll.06%. CONCLUSION:The resultsof statistical analysis showed that two formulations were bioequivalent.

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Key concepts: Bioequivalence, Bioavailability, Cmax, Capsule, Pharmacokinetics, Crossover study, Pharmacology, Medicine