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

Whanin Pharmaceutical Company

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Clozaril 100 mg (Clozapine); Drug: WID-CLZ18

Study type: Interventional

Funder types: Industry

Identifiers

NCT04849026

WID-CLZ18-BE

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Group A

Experimental group

Description:

1. Period 1: WID-CLZ18 2. Period 2: Clozaril 100 mg (Clozapine)

Treatment:

Drug: WID-CLZ18

Drug: Clozaril 100 mg (Clozapine)

Group B

Experimental group

Description:

1. Period 1: Clozaril 100 mg (Clozapine) 2. Period 2: WID-CLZ18

Treatment:

Drug: WID-CLZ18

Drug: Clozaril 100 mg (Clozapine)