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.

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.