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

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.

Objective:

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Torrent's Quetiapine Fumarate Tablets

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Hyderabad, India, 500034
    • Asha hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 2, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: PK-08-111