NCT02814058

Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	zolpidem hemitartarate 1.75 mg - Sequency 1	zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2)
DRUG	zolpidem hemitartarate 1.75 mg - Sequency 2	zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2)

Timeline

• Start date: 2017-07-05
• Primary completion: 2018-02-22
• Completion: 2018-02-22
• First posted: 2016-06-27
• Last updated: 2018-06-08

Locations

1 site across 1 country: Brazil