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

An open label, balanced, randomized, two treatment, two-period, two-sequence, crossover, multicentric experimental comparative evaluation of Clozapine modified release capsule 200 mg once daily (Test drug, Intas Pharmaceuticals Ltd., India) with LeponexÂ® 100 mg tablets twice daily (Reference drug, Novartis Farmaceutica, S.A Spain), under fasting conditions after multiple dose administration at steady state in adult schizophrenic patients stabilized on Clozapine 200 mg per day

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000115

Enrollment

Registered

2010-04-01

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: Clozapine 200 mg, modified release capsules,once daily Control Intervention1: Leponex&reg

100 mg tablets, twice daily: Patients will be administered either Test (once daily i.e. morning dose) or Reference product (twice daily i.e. morning and evening dose) for the first ten days as per ran

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 (LeponexÂ®100 mg tablets, twice daily) in adult Schizophrenic patients (stabilized on Clozapine 200 mg per day) under fasting conditions.Timepoint: NIL	—

Secondary

Measure	Time frame
To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: NIL	—

Countries

India

Contacts

Public ContactMr Harshit Shah

NIL

praveenshetty@lambda-cro.com91-7940202098

Outcome results

None listed

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