Status:
COMPLETED
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
Lead Sponsor:
Laboratorio Elea Phoenix S.A.
Collaborating Sponsors:
DominguezLab S.R.L.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03317236
Start Date
March 13 2017
End Date
October 1 2017
Last Update
October 23 2017
Active Locations (1)
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1
DominguezLab
Paraná, Entre Ríos Province, Argentina, 3102