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The purpose of this study is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.
Full description
This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and postprandial administration. Sample size is 28 volunteers, male and female, aged from 18 to 50 years old.
This is an open-label, randomized, crossover study. Each volunteer will be randomized to one of the following sequencies:
Primary objective is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 3.5 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.
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28 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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