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Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation

NCT02817750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-06-11

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 3.5 mg in male and female healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial)

zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial

DRUG

zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)

zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • José Pedrazzoli Júnior, PhD · UNIFAG - Universidade 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 NCT02817750 on ClinicalTrials.gov