Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
NCT ID: NCT03317236
Last Updated: 2017-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2017-03-13
2017-10-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Reference - Test
A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).
Quetiapine
A fixed 50 mg exteded release formulation.
Test - Reference
A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).
Quetiapine
A fixed 50 mg exteded release formulation.
Interventions
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Quetiapine
A fixed 50 mg exteded release formulation.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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DominguezLab S.R.L.
UNKNOWN
Laboratorio Elea Phoenix S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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María C Fritz, MD
Role: PRINCIPAL_INVESTIGATOR
DominguezLab S.R.L.
Locations
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DominguezLab
Paraná, Entre Ríos Province, Argentina
Countries
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Other Identifiers
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PRO-BEQ-QTP-002-V.01
Identifier Type: -
Identifier Source: org_study_id