This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old. Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product. Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics. Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Area under the curve(0-last)
Time frame: 24 hours
Area under the curve(0-all)
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
Time of the last measurable (positive) concentration (tlast)
Time frame: 24 hours
Area under the first moment of the plasma concentration-time curve extrapolated from time zero to infinity as a percentage of total AUC
Time frame: 24 hours
Number of adverse events
Time frame: 60 days
Intensity of adverse events
Time frame: 60 days
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