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Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.

NCT03317236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-23

No results posted yet for this study

Summary

Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.

Conditions

  • Healthy

Interventions

DRUG

Quetiapine

A fixed 50 mg exteded release formulation.

Sponsors & Collaborators

  • DominguezLab S.R.L.

    collaborator UNKNOWN

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Principal Investigators

  • María C Fritz, MD · DominguezLab S.R.L.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2017-10-01
Completion
2017-10-01

Countries

  • Argentina

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 NCT03317236 on ClinicalTrials.gov