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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial
zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting
UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia
Bragança Paulista, São Paulo, Brazil
Area under the curve (0-last)
Time frame: 24 hours
Area under the curve (0-inf)
Time frame: 24 hours
Half life (t1/2)
Time frame: 24 hours
Elimination rate constant (Ke)
Time frame: 24 hours
Maximum serum concentration (Cmax)
Time frame: 24 hours
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Time frame: 24 hours
Volume of distribution (Vd)
Time frame: 24 hours
Clearance (C)
Time frame: 24 hours
Number of adverse events
Time frame: 60 days
Intensity of adverse events
Time frame: 60 days
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