Bioequivalence study of Quetiapine Fumarate prolonged-release tablets EQ 400 mg base in patients suffering from schizophrenia

Not Applicable

Completed

• Conditions: Health Condition 1: null- schizophrenia

• Registration Number: CTRI/2015/05/005820
• Lead Sponsor: Amneal Pharmaceuticals Company GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

1. Either sex, aged 18 to 65 years (both inclusive) having clinical diagnosis of schizophrenia (DSM IV-TR)

2. Receiving Quetiapine Fumarate prolonged-release tablets treatment for at least 1 month prior to randomization and is on Quetiapine Fumarate prolonged-release tablets EQ 400 mg base once daily dosage at the time of screening.

3. Willing and able to comply with housing, restrictions and other protocol requirements as indicated by signed written informed consent witnessed by a legally acceptable representative.

4. Females of childbearing potential (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation) must have a negative pregnancy test (at screening, before randomization and before check-in to housing e.g. day 0) as well as must be non-lactating at screening and must agree to use an effective contraceptive method during study.

Exclusion Criteria

1. History of allergic reactions to Quetiapine or other component of the prolonged-release formulation.

2. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, alcoholic and other toxic psychoses, severe tardive dyskinesia, or idiopathic Parkinsonâ??s disease.

3. History of suicidal tendencies (e.g. suicidal attempts) 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.

4. History of Neuroleptic Malignant Syndrome, cardiovascular disease [ischemic heart disease (including myocardial infarction), heart failure (including congestive heart failure or significant heart hypertrophy) or conduction abnormalities (including bradyarrythmia, congenital QT prolongation or family history of QT prolongation)], cerebrovascular disease, drug induced leucopenia/ neutropenia, seizures or with conditions that potentially lower the seizure threshold e.g. Alzheimerâ??s dementia

5. History of multiple syncopal episodes or presence of significant orthostatic hypotension at screening or before check-in to housing on day 0; Orthostatic hypotension will be considered when there is drop in systolic blood pressure of 30 mm Hg or more or diastolic blood pressure of 20 mm Hg or more on standing from supine measurements.

6. Current/ recent (within 3 months) history of uncontrolled epilepsy or risk for seizures

7. A medical or surgical condition that might interfere with the absorption, metabolism or excretion of Quetiapine

8. Drug abuse or alcohol dependence in last 1 year period before enrolment (except dependence in full remission), as defined by DSM IV-TR criteria and as positive result in breath alcohol testing/ urine screen for drug of abuse (except for prescribed benzodiazepines).

9. Any of the following investigational abnormality in screening:

ï?· WBC count 3000/mm3 (3.0x109/l),

ï?· Absolute Neutrophil Count 1500/mm3 (1.5x109/l),

ï?· Serum creatinine 1.5 mg/dL

ï?· QTc 500 milliseconds (in ECG of screening or day 0)

ï?· SGOT/ SGPT 3 times Upper Limit of Normal range (ULN)

ï?· HbA1c 9%

ï?· Reactive to antiHIV, HBsAg, antiHCV

10. Use of any contraindicated medications in the 14 days preceding enrolment

Use of any of the following in the 14 days preceding enrolment

Study & Design

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