Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
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
1 other identifier
interventional
33
1 country
1
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 tablet (Clozapine) after oral administration in schizophrenia patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Jan 2021
Typical duration for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2022
CompletedMay 16, 2023
May 1, 2023
1.6 years
April 14, 2021
May 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Tmax
Up to 12 hours
T1/2
Up to 12 hours
R
Up to 12 hours
Cmin
Up to 12 hours
Fluctuation
Up to 12 hours
Study Arms (2)
Group A
EXPERIMENTAL1. Period 1: WID-CLZ18 2. Period 2: Clozaril 100 mg (Clozapine)
Group B
EXPERIMENTAL1. Period 1: Clozaril 100 mg (Clozapine) 2. Period 2: WID-CLZ18
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Whan In Pharm.
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo-Hyun Yoon
Department of Psychiatry, Naju National Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 19, 2021
Study Start
January 15, 2021
Primary Completion
August 14, 2022
Study Completion
August 14, 2022
Last Updated
May 16, 2023
Record last verified: 2023-05