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OpenTrials
Completed

NCT Number: NCT03317236

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DominguezLab

Paraná, Entre Ríos Province, 3102, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine

Drug

A fixed 50 mg exteded release formulation.

Primary outcomes

  1. Cmax

    Time frame: 36 hours

    Maximum plasma concentration

  2. AUC

    Time frame: 36 hours

    Area under curve

Sponsors and collaborators

Lead sponsor

Laboratorio Elea Phoenix S.A.

Industry

Collaborators

  • DominguezLab S.R.L.

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2017
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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