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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Quetiapine

• Registration Number: NCT03317236
• Lead Sponsor: Laboratorio Elea Phoenix S.A.

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 single-dose, two-way crossover design.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Status Verified: 2017-10
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Last Update Submitted: 2017-10-18
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference - Test	Quetiapine	A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).
Test - Reference	Quetiapine	A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).

Primary Outcome Measures

Name	Time	Method
Cmax	36 hours	Maximum plasma concentration
AUC	36 hours	Area under curve

Trial Locations

Locations (1)

DominguezLab; 🇦🇷 Paraná, Entre Ríos, Argentina