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

October 18, 2017 updated by: Laboratorio Elea Phoenix S.A.

Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Entre Ríos
      • Paraná, Entre Ríos, Argentina, 3102
        • DominguezLab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent.
  • Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
  • Gender: males and non pregnant females
  • Age: 18 to 55 years.
  • Body mass index: 19 to 27 kg/m^2.

Exclusion Criteria:

  • History of liver or renal disease, or psychiatric disorders.
  • History of drug or alcohol abuse during the previous two years.
  • Smokers of more than 10 cigarrettes a day.
  • Any kind of medicines taken during the previous two weeks.
  • Any history of disease or disorders clinically significant according to the Principal Investigator.
  • Abnormal ECG.
  • Abnormal chest X-ray.
  • Hypersensitivity to quetiapine or excipients within the formulations.
  • Positive diagnostic test for HIV or hepatitis A, B or C virus.
  • Breast feeding females.
  • Positive beta-HCG test.
  • Positive drug test in urine.
  • Participation in clinical trials in the previous three months.
  • Blood donation in the previous three months.
  • Clinically significant laboratory results.
  • Subjects seeking to initiate any medical or pharmacological treatment.
  • Subjects unwilling to keep fasting or diet indications.
  • Uncooperative subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reference - Test
A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).
Drug: Quetiapine
A fixed 50 mg exteded release formulation.
Experimental: Test - Reference
A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).
Drug: Quetiapine
A fixed 50 mg exteded release formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 36 hours
Maximum plasma concentration
36 hours
AUC
Time Frame: 36 hours
Area under curve
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorio Elea Phoenix S.A.

Collaborators

DominguezLab S.R.L.

Investigators

  • Principal Investigator: María C Fritz, MD, DominguezLab S.R.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-BEQ-QTP-002-V.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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