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

Sponsor

Laboratorio Elea Phoenix S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT03317236

Collaborator

DominguezLab S.R.L. (Other)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Quetiapine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single-dose, two-way crossover.Single-dose, two-way crossover.

Masking:

None (Open Label)

Primary Purpose:

Other

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.

Actual Study Start Date :

Mar 13, 2017

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reference - Test A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).	Drug: Quetiapine A fixed 50 mg exteded release formulation.
Experimental: Test - Reference A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).	Drug: Quetiapine A fixed 50 mg exteded release formulation.

Arm

Intervention/Treatment

Experimental: Reference - Test

A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R).

Drug: Quetiapine

A fixed 50 mg exteded release formulation.

Experimental: Test - Reference

A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T).

Drug: Quetiapine

A fixed 50 mg exteded release formulation.

Outcome Measures

Primary Outcome Measures

Cmax [36 hours]
Maximum plasma concentration
AUC [36 hours]
Area under curve

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DominguezLab	Paraná	Entre Ríos	Argentina	3102

Sponsors and Collaborators

Laboratorio Elea Phoenix S.A.
DominguezLab S.R.L.

Investigators

Principal Investigator: María C Fritz, MD, DominguezLab S.R.L.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laboratorio Elea Phoenix S.A.

ClinicalTrials.gov Identifier:

NCT03317236

Other Study ID Numbers:

PRO-BEQ-QTP-002-V.01

First Posted:

Oct 23, 2017

Last Update Posted:

Oct 23, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Laboratorio Elea Phoenix S.A.

Bioequivalence

Quetiapine

Additional relevant MeSH terms:

Quetiapine Fumarate

Study Results

No Results Posted as of Oct 23, 2017