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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-dose, two-way crossover.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Quetiapine