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

Schizophrenia 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634373
• Other study ID #: PK-08-111
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2012
• Last updated: July 2, 2012

Study information

• Verified date: July 2012
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Torrent's Quetiapine Fumarate Tablets

Locations

Country	Name	City	State
India	Asha Hospital	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

India,