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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Clozaril 100 mg (Clozapine); Drug: WID-CLZ18

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jun Beom Kim; Phone Number: +82 2 405 3148; Email: jbkim88@whanin.com
• Study Contact Backup: Name: Yoo Jin Park; Phone Number: +82 2 405 3075; Email: yoojin.park@whanin.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Whan In Pharm.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Period 1: WID-CLZ18; Period 2: Clozaril 100 mg (Clozapine)	Drug: Clozaril 100 mg (Clozapine); 2 Doses/Day for 10 days; Drug: WID-CLZ18; 2 Doses/Day for 10 days
Experimental: Group B; Period 1: Clozaril 100 mg (Clozapine); Period 2: WID-CLZ18	Drug: Clozaril 100 mg (Clozapine); 2 Doses/Day for 10 days; Drug: WID-CLZ18; 2 Doses/Day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Whanin Pharmaceutical Company
• Investigators: Principal Investigator: Bo-Hyun Yoon, Department of Psychiatry, Naju National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): August 14, 2022
• Study Completion (Actual): August 14, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Clozapine
• Other Study ID Numbers: WID-CLZ18-BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No