A clinical trial to study Bioequivalence of two formulations of Quetiapine fumarate 300mg in Adult Patients suffering from schizophrenia.

Completed

• Conditions: Adult Schizophrenic PatientsAlready Receiving or Stabilized with Qetiapine

• Registration Number: CTRI/2011/08/001949
• Lead Sponsor: Amneal Pharmaceuticals LLC

Brief Summary

This is a Multicentrer, Open Label, Randomized, Two-Treatment, Two-Sequence, Crossover, Steady state Bioequivalence Study of Two formulations of Quetiapine fumarate tablet 300 mg in Adult Patients suffering from schizophrenia. It is expected that sponsors test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. Anticipated date for first patient enrolment in the study is end of August, 2011.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-29
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adult schizophrenic patients with body mass index (BMI) between 18 and 35kg/m2, inclusive, and aged between 18 and 60 years, inclusive.
• on stable regimen with Quetiapine 300 mg IR preparation Q12h 2.
• Confirmed by a psychiatrist according to the Diagnostic and Statistical Manual IV (DSM IV) criteria 3.
• Able to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the investigator and to comply with the requirements of the entire study 4.
• Signed written informed consent prior to inclusion in the study witnessed by a legally acceptable representative or guardian 5.
• Should be otherwise healthy as determined by physical examination, medical history, and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray 6.
• Body weight ≥ 45kgs 7.
• Adequate hemoglobin i.e. ≥10gm/dL 8.
• Adequate renal function at screening as defined by Creatinine 1.5 X ULN for the clinical laboratory 9.
• Female patients of childbearing potential must be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, etc.
• during the study.

Exclusion Criteria

• Known to have significant orthostatic hypotension 2.
• Known to have tachycardia or tachyarrhythmia 3.
• Bouts of uncontrolled seizures 4.
• Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson¡¯s disease or Alzheimer¡¯s dementia 5.
• Used any investigational drug within 3 months before Screening 6.
• On anticoagulants 7.
• Blood donations/ losses within 60 days of Screening 8.
• history of arrhythmias, hypokalemia, hypomagnesemia, or congenital QT prolongation History of multiple syncopal episodes 9.
• History of alcoholism within 3 months prior to Screening 10.
• History of drug abuse or dependence within 3 months prior to Screening 11.
• A value at Screening is greater than 1.5 times the upper limit of reference range for AST, ALT, direct bilirubin, total triglycerides, or total cholesterol 12.
• Contraindications or hypersensitivity to the use of Quetiapine or related group of drugs 13.
• Class III heart failure with evidence of recent progression, or Class IV heart failure per NYHA functional classification system 14.
• Uncontrolled and untreated hypertension 15.
• Myocardial infarction or acute coronary syndrome within 6 months prior to Screening 16.
• Significant pre-existing gastrointestinal co-morbidities that would preclude compliance with oral medication.
• History of suicidal tendencies within the past 3 months prior to Screening or immediate risk of harm to self or other at the time of Screening, as judged by the investigator 18.
• Uncontrolled and un-treated diabetes mellitus 19.
• An unusual or abnormal diet, for whatever reason e.g. religious fasting 20.
• Smoking¡Ý 9 cigarettes/beedies per day 21.
• With bleeding disorders 22.
• On treatment with alpha adrenergic receptor blocking agents 23.
• Pregnant females as determined by positive serum or urine hCG test at Screening or prior to the first dose of study medication (Day 1) 24.
• Lactating female 25.
• On class 1A antiarrhythmics, class III antiarrhythmics, antipsychotics, antibiotics, other drugs associated with QT prolongation 26.
• On drugs which are enzyme inducer or inhibitors of CYP450 3A4, 5, and 7.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. AUC0-tau: Area under the plasma concentration to time curve over the steady state	Dosing interval on day 5 and day 10.
dosing interval.	Dosing interval on day 5 and day 10.
3. Cmin-ss: Minimum concentration over the steady state dosing interval.	Dosing interval on day 5 and day 10.
2. Cmax-ss: Maximum concentration over the steady state dosing interval.	Dosing interval on day 5 and day 10.

Secondary Outcome Measures

Name	Time	Method
1. Css-avg: Average concentration over the steady state dosing interval.	2. Percentage fluctuation: [Cmax-ss – Cmin-ss / Css-avg] x 100

Trial Locations

Locations (3)

Anand Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

Divyam Hospital; 🇮🇳 Surat, GUJARAT, India

Vraj Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Anand Hospital

🇮🇳Gandhinagar, GUJARAT, India

Dr Rajendra Anand

Principal investigator

079-23238853

drrajendraanand@yahoo.com