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

NCT04849026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Clozaril 100 mg (Clozapine)

2 Doses/Day for 10 days

DRUG

WID-CLZ18

2 Doses/Day for 10 days

Sponsors & Collaborators

  • Whanin Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Bo-Hyun Yoon · Department of Psychiatry, Naju National Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-08-14
Completion
2022-08-14

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849026 on ClinicalTrials.gov