Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01634373
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited

Brief Summary:


Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg.

Study Design:

Randomized, Two-Way, Crossover, multiple Dose, and Open-Label

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Torrent's Quetiapine Fumarate Tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Steady State Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 300 mg Tablet [Reference Formulation; AstraZeneca, USA] in Schizophrenic Patients.

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sex: Male of female
  • Age: 25-65 years
  • Patients who are receiving a stable daily dose of quetiapine 300 mg every 12 hourly for atlist one month
  • Patient willing to adhere to the protocol requirements

Exclusion Criteria:

  • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  • Clinically significant abnormal ECG.
  • Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
  • Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
  • History of allergic reactions to quetiapine or other chemically related psychotropic drugs.
  • Concurrent primary psychiatric or neurological diagnosis including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease.
  • Existence of any surgical or medical condition, which in the judgement of the Principal Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of patients.
  • Concurrent use of other drugs known to suppress bone marrow function.
  • HIV, HCV, HBsAg positive.
  • Expected changes in concomitant medications during the period of study.
  • A history of epilepsy or risk for seizures
  • positive urine drug of abuse test at enrollment.
  • A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental disorders IV(DSM-IV) criteria during the 6 month period immediately prior to study entry.
  • A total white blood cell count below 4000/ml, or absolute neutrophil count below 2000/ml
  • Female patients with pregnancy or Breast feeding or intend to become pregnant during the study and not able to follow contraception methods.
  • History of multiple syncopal episodes.
  • Administration any study drugs in last 3 months prior to entry in the study.
  • History of significant blood loss due to any reason in the past 3 months.
  • Any pre-existing bleeding disorder.

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 identifier (NCT number): NCT01634373

Asha Hospital
Hyderabad, India, 500034
Sponsors and Collaborators
Torrent Pharmaceuticals Limited

Responsible Party: Torrent Pharmaceuticals Limited Identifier: NCT01634373     History of Changes
Other Study ID Numbers: PK-08-111
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs