Healthy Clinical Trial
Official title:
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation, With Fasting and Postprandial Administration, in Male and Female Healthy Volunteers, Produced by Biolab Sanus Farmacêutica Ltda
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.
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:
- Sequency 1: zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 1)
and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2)
- Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1)
and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2)
Formulation will be administered in a single dose, orally in each period. The volunteers
will be admitted in two different periods of 36 hours each, when investigational product
will be administered and blood samples will be collected at pre-determined periods of
time up to 24 hours for pharmacokinetics evaluation.
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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