Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
NCT ID: NCT04849026
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2021-01-15
2022-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Group A
1. Period 1: WID-CLZ18
2. Period 2: Clozaril 100 mg (Clozapine)
Clozaril 100 mg (Clozapine)
2 Doses/Day for 10 days
WID-CLZ18
2 Doses/Day for 10 days
Group B
1. Period 1: Clozaril 100 mg (Clozapine)
2. Period 2: WID-CLZ18
Clozaril 100 mg (Clozapine)
2 Doses/Day for 10 days
WID-CLZ18
2 Doses/Day for 10 days
Interventions
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Clozaril 100 mg (Clozapine)
2 Doses/Day for 10 days
WID-CLZ18
2 Doses/Day for 10 days
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
20 Years
65 Years
ALL
No
Sponsors
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Whanin Pharmaceutical Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bo-Hyun Yoon
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, Naju National Hospital
Locations
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Whan In Pharm.
Seoul, , South Korea
Countries
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Other Identifiers
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WID-CLZ18-BE
Identifier Type: -
Identifier Source: org_study_id
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