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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317236
• Other study ID #: PRO-BEQ-QTP-002-V.01
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2017
• Last updated: October 18, 2017
• Start date: March 13, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Laboratorio Elea S.A.C.I.F. y A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Quetiapine
A fixed 50 mg exteded release formulation.

Locations

Country	Name	City	State
Argentina	DominguezLab	Paraná	Entre Ríos

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorio Elea S.A.C.I.F. y A.	DominguezLab S.R.L.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration	36 hours
Primary	AUC	Area under curve	36 hours