Bioequivalence Study of Quetiapine in Healthy Volunteers,... | EligiMed

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.

CompletadoFase 4ClinicalTrials.gov

ID: NCT03317236Tipo: INTERVENTIONALInicio: 13 de mar de 2017Fin estimado: 1 de oct de 2017

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

Any history of disease or disorders clinically significant according to the Principal Investigator.
Abnormal ECG.
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.
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.

Intervenciones

drug

Quetiapine

A fixed 50 mg exteded release formulation.

Ubicaciones

DominguezLab

Paraná, Entre Ríos Province, Argentina

Patrocinadores

PrincipalLaboratorio Elea Phoenix S.A.

ColaboradorDominguezLab S.R.L.

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