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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

A Multicentric Open Label, Balanced, Randomized, Two Treatment, Two-Period, Two-Sequence, Crossover, Steady State Bioequivalence Evaluation of Clozapine Extended Release Capsule 200 mg once daily (Test Drug, Intas Pharmaceuticals Limited, India) with Clozaril® 100 mg Tablets twice daily (Reference Drug, Novartis Pharmaceuticals Corporation, Usa) after multiple dose administration in Adult Schizophrenic Patients under Fasting conditions- Pilot Study - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/005970
Enrollment
24
Registered
2015-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: Clozapine Extended Release Capsule, Intas Pharmaceuticals Limited: Dose-200 mg Frequency-once daily Mode of Administration-oral Duration of treatment-10 days Control Intervention1: Cloz

Sponsors

Intas Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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 6.Pregnant or lactating females.

Design outcomes

Primary

MeasureTime frame
C max,ss and AUC 0-24Timepoint: Day 10 and day 20—

Secondary

MeasureTime frame
â?¢ T max,ss , C min,ss , % PTF, Swing and C ss,av â?¢ C pdTimepoint: â?¢ Day 10 and 20 â?¢ Day 07 to day10 and day 17 to day 20—

Countries

India

Contacts

Public ContactSheejith K

Lambda Therapeutic Research Ltd

yogeshpatel@lambda-cro.com07940202353

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026