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Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation

NCT02814058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-06-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • José Pedrazzoli Júnior, PhD · UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2018-02-22
Completion
2018-02-22

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02814058 on ClinicalTrials.gov