Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Clozaril 100 mg (Clozapine); Drug: WID-CLZ18

• Registration Number: NCT04849026
• Lead Sponsor: Whanin Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Primary Completion: 2022-08-14
• Study Completion: 2022-08-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Clozaril 100 mg (Clozapine)	1. Period 1: WID-CLZ18 2. Period 2: Clozaril 100 mg (Clozapine)
Group A	WID-CLZ18	1. Period 1: WID-CLZ18 2. Period 2: Clozaril 100 mg (Clozapine)
Group B	Clozaril 100 mg (Clozapine)	1. Period 1: Clozaril 100 mg (Clozapine) 2. Period 2: WID-CLZ18
Group B	WID-CLZ18	1. Period 1: Clozaril 100 mg (Clozapine) 2. Period 2: WID-CLZ18

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Whan In Pharm.; 🇰🇷 Seoul, Korea, Republic of