Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Quetiapine Fumarate
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.