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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03317236

Enrollment

Registered

2017-10-23

Start date

2017-03-13

Completion date

2017-10-01

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioequivalence, Quetiapine

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.

Interventions

DRUGQuetiapine

A fixed 50 mg exteded release formulation.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Single-dose, two-way crossover.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax	36 hours	Maximum plasma concentration
AUC	36 hours	Area under curve

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026