NCT01634373

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

First QC Date

June 27, 2012

Last Update Submit

July 2, 2012

Conditions

Schizophrenia

Interventions

Torrent's Quetiapine Fumarate TabletsDRUG

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asha Hospital

Hyderabad, 500034, India

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 6, 2012

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

IN(1)