Healthy Volunteers Clinical Trial
Official title:
Phase I Randomized Clinical Trial of Evaluation of Zolpidem Hemitartarate Pharmacokinetics (Orodispersible Tablet 1.75 mg and 3.50 mg) After Single Dose Oral Administration in Male and Female Healthy Subjects
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.
n/a
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