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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04849026

Enrollment

Registered

2021-04-19

Start date

2021-01-15

Completion date

2022-08-14

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGClozaril 100 mg (Clozapine)

2 Doses/Day for 10 days

DRUGWID-CLZ18

2 Doses/Day for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026