Healthy Clinical Trial
Official title:
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 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 1.75 mg in male and female healthy volunteers.
This is a phase I study of zolpidem hemitartarate orodispersible tablet 1.75 mg in fasting
and postprandial administration. Sample size is 28 healthy 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 1.75 mg in fasting (period 1) and zolpidem hemitartarate
1.75 mg postprandial (period 2) Sequency 2: zolpidem hemitartarate 1.75 mg postprandial
(period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2) Formulation will be
administered in a single dose, orally in each period. Trial 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 1.75 mg in healthy volunteers. As a secondary objective,
it will be evaluated if there is any pharmacokinetics difference between genders.
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