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

Laboratorio Elea

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03317236

PRO-BEQ-QTP-002-V.01

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.