Back to resultsSteady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Torrent's Quetiapine Fumarate Tablets
Sponsored by
About this trial
This is an interventional trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Asha Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01634373
First Posted
June 27, 2012
Last Updated
July 2, 2012
Sponsor
Torrent Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT01634373
Brief Title
Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torrent Pharmaceuticals Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Torrent's Quetiapine Fumarate Tablets
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asha Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
12. IPD Sharing Statement
Learn more about this trial
Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets
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