Status:
COMPLETED
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
Lead Sponsor:
Whanin Pharmaceutical Company
Conditions:
Schizophrenia
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief 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 tabl...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04849026
Start Date
January 15 2021
End Date
August 14 2022
Last Update
May 16 2023
Active Locations (1)
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1
Whan In Pharm.
Seoul, South Korea