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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849026
• Other study ID #: WID-CLZ18-BE
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2021
• Est. completion date: August 14, 2022

Study information

• Verified date: May 2023
• Source: Whanin Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 14, 2022
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Clozaril 100 mg (Clozapine)
2 Doses/Day for 10 days
• WID-CLZ18
2 Doses/Day for 10 days

Locations

Country	Name	City	State
Korea, Republic of	Whan In Pharm.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Whanin Pharmaceutical Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum blood concentration in steady state	Up to 12 hours
Primary	AUC0-12	Area under the concentration-time curve from zero to 12 hours at steady state	Up to 12 hours
Secondary	Tmax	Time to maximum blood concentration	Up to 12 hours
Secondary	T1/2	Terminal elimination half life	Up to 12 hours
Secondary	R	Accumulation rate	Up to 12 hours
Secondary	Cmin	Steady-state peak plasma concentration	Up to 12 hours
Secondary	Fluctuation	(Cmax-Cmin)/Cav	Up to 12 hours