This is a Bioequivalence study of two formulations of Clozapine in adult schizophrenic patients.

Phase 1

Completed

• Conditions: Health Condition 1: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2010/091/000115
• Lead Sponsor: Intas Pharmaceuticals Limited

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: 24

Inclusion Criteria

1.Written informed consent for participation in the study by the patient and Patients Legally Acceptable Representative (LAR).

2.Patient has a documented clinical diagnosis of schizophrenia according to DSM IV-TR.

3.Patients have a diagnosis of treatment-resistant schizophrenia {Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration. (Atleast 15 days for each antipsychotic agent.)},, or have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics

4.Having a Body Mass Index (BMI) between 18 and 30 (Both inclusive), calculated as weight in kg / height in m2.

5. Able to comply with study procedures in the opinion of the investigator.

Exclusion Criteria

1.Patient with known hypersensitivity to clozapine or any other component of the drug.
2.Patient with a known intolerance or lack of response to previous treatment with clozapine.
3.Significant orthostatic hypotension (i.e., a drop in supine systolic blood pressure of 30 mm Hg or more or a drop in supine diastolic blood pressure of 20 mm Hg or more within 2-3 minutes of standing)
4.History of syncope or orthostatic hypotension.
5.Known case of HIV infection.
6.Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than
100 beats per minute at screening and Day 0.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsors formulation (Clozapine Modified Release Capsules 200 mg, Once daily) with respect to the reference formulation (Leponex®100 mg tablets, twice daily) in adult Schizophrenic patients (stabilized on Clozapine 200 mg per day) under fasting conditions.Timepoint: NI

Secondary Outcome Measures

Name	Time	Method
To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: NI