NCT02607696

Pharmacokinetics of Zolpidem Orodispersible Tablet

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Zolpidem Hemitartarate

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-10-01
• First posted: 2015-11-18
• Last updated: 2017-02-01