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

NCT03317236 | Completed Phase 4

• 1 other identifier: PRO-BEQ-QTP-002-V.01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Quetiapine

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration

  36 hours

• AUC

  Area under curve

  36 hours

Study Arms (2)

Reference - Test

EXPERIMENTAL

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

Drug: Quetiapine

Test - Reference

EXPERIMENTAL

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

Drug: Quetiapine

Interventions

Quetiapine DRUG

A fixed 50 mg exteded release formulation.

Reference - Test; Test - Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead
• DominguezLab S.R.L.: collaborator

Study Sites (1)

DominguezLab

Paraná, Entre Ríos Province, 3102, Argentina

Location

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• María C Fritz, MD

  DominguezLab S.R.L.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, two-way crossover.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: March 13, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 23, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)