Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18

Study Overview
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Brief Summary
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This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.

Official Title
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A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Clozaril 100 mg (Clozapine)
* Drug: WID-CLZ18


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Males and females adults aged 20 to 65 years Diagnosed as schizophrenia prior to the screening visit On treatment with a stable dose of clozapine 200 mg/day for at least 12 weeks before the screening visit and taken at 100 mg twice daily during the study period Main Exclusion Criteria: Subjects who have a medical history specified in protocol Subjects with confirmed abnormal laboratory values specified in protocol Subjects who have a medication history or safety risks specified in protocol Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol Subjects who are expected to have the prohibited concomitant medication therapy during the study period Pregnant women or breast-feeding women or men and women who has possibility of pregnancy Subjects who are not suitable for the clinical trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: WID-CLZ18 Period 2: Clozaril 100 mg (Clozapine) | Drug: Clozaril 100 mg (Clozapine)<br>* 2 Doses/Day for 10 days<br>Drug: WID-CLZ18<br>* 2 Doses/Day for 10 days<br>|
| Experimental: Group B<br>Period 1: Clozaril 100 mg (Clozapine) Period 2: WID-CLZ18 | Drug: Clozaril 100 mg (Clozapine)<br>* 2 Doses/Day for 10 days<br>Drug: WID-CLZ18<br>* 2 Doses/Day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum blood concentration in steady state | Up to 12 hours | 
| AUC0-12 | Area under the concentration-time curve from zero to 12 hours at steady state | Up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time to maximum blood concentration | Up to 12 hours | 
| T1/2 | Terminal elimination half life | Up to 12 hours | 
| R | Accumulation rate | Up to 12 hours | 
| Cmin | Steady-state peak plasma concentration | Up to 12 hours | 
| Fluctuation | (Cmax-Cmin)/Cav | Up to 12 hours |