A study of Bioequivalence Evaluation of Clozapine Capsule 200 mg once daily (Test Drug, Intas Pharmaceuticals Limited, India) with Clozaril® 100 mg Tablets twice daily (Reference Drug, Novartis Pharmaceuticals Corporation, Usa) in Adult Schizophrenic Patients under Fasting conditions

Not Applicable

Completed

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

• Registration Number: CTRI/2015/07/005970
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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

2.Patient has a documented clinical diagnosis of schizophrenia according to DSM IV-TR at least six months prior to screening

3.Patients have a diagnosis of treatment-resistant schizophrenia (Treatment resistance is the failure to respond to two or more antipsychotic medications given in therapeutic dose for more than six weeks or more)

4.Patients between 18 and 60 years of age (both inclusive)

5.Having a BMI between 18 and 30 (both inclusive),calculated as weight in kg/height in m2

6.Patients have been on a daily stable dose of 200 mg clozapine formulation for at least 3 month prior to screening visit

7.Not having any significant diseases or clinically significant abnormal findings except schizophrenia.

Exclusion Criteria

1.Patient with known hypersensitivity/ intolerance to clozapine or any other component of the drug.

2.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)

3.Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.

4.Supine blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beat per minute at screening and Day 1.

5.A total white blood cell count below 4000/mL, or an absolute neutrophil count <2000/ mL performed at the screening and a day prior to randomization.

6.Pregnant or lactating females.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
C max,ss and AUC 0-24Timepoint: Day 10 and day 20

Secondary Outcome Measures

Name	Time	Method
â?¢ T max,ss , C min,ss , % PTF, Swing and C ss,av <br/ ><br>â?¢ C pdTimepoint: â?¢ Day 10 and 20 <br/ ><br>â?¢ Day 07 to day10 and day 17 to day 20