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

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ClinicalTrials.gov Identifier: NCT03317236
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
DominguezLab S.R.L.
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : March 13, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cmax [ Time Frame: 36 hours ]
    Maximum plasma concentration

  2. AUC [ Time Frame: 36 hours ]
    Area under curve



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317236


Locations
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Argentina
DominguezLab
Paraná, Entre Ríos, Argentina, 3102
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.
DominguezLab S.R.L.
Investigators
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Principal Investigator: María C Fritz, MD DominguezLab S.R.L.

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Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT03317236     History of Changes
Other Study ID Numbers: PRO-BEQ-QTP-002-V.01
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorio Elea S.A.C.I.F. y A.:
Bioequivalence
Quetiapine
Additional relevant MeSH terms:
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Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs