Overview
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
Status:
Recruiting
Recruiting
Trial end date:
2021-12-31
2021-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Whanin Pharmaceutical CompanyTreatments:
Clozapine
Criteria
Main Inclusion Criteria:1. Males and females adults aged 20 to 65 years
2. Diagnosed as schizophrenia prior to the screening visit
3. 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:
1. Subjects who have a medical history specified in protocol
2. Subjects with confirmed abnormal laboratory values specified in protocol
3. Subjects who have a medication history or safety risks specified in protocol
4. Subjects who can not comply with requirements of pharmacokinetic sampling as per
protocol
5. Subjects who are expected to have the prohibited concomitant medication therapy during
the study period
6. Pregnant women or breast-feeding women or men and women who has possibility of
pregnancy
7. Subjects who are not suitable for the clinical trial