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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clozaril 100 mg (Clozapine)
WID-CLZ18
Sponsored by
Whanin Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Whan In Pharm.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2021
Last Updated
May 15, 2023
Sponsor
Whanin Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT04849026
Brief Title
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 14, 2022 (Actual)
Study Completion Date
August 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Whanin Pharmaceutical Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Period 1: WID-CLZ18 Period 2: Clozaril 100 mg (Clozapine)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Period 1: Clozaril 100 mg (Clozapine) Period 2: WID-CLZ18
Intervention Type
Drug
Intervention Name(s)
Clozaril 100 mg (Clozapine)
Intervention Description
2 Doses/Day for 10 days
Intervention Type
Drug
Intervention Name(s)
WID-CLZ18
Intervention Description
2 Doses/Day for 10 days
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum blood concentration in steady state
Time Frame
Up to 12 hours
Title
AUC0-12
Description
Area under the concentration-time curve from zero to 12 hours at steady state
Time Frame
Up to 12 hours
Secondary Outcome Measure Information:
Title
Tmax
Description
Time to maximum blood concentration
Time Frame
Up to 12 hours
Title
T1/2
Description
Terminal elimination half life
Time Frame
Up to 12 hours
Title
R
Description
Accumulation rate
Time Frame
Up to 12 hours
Title
Cmin
Description
Steady-state peak plasma concentration
Time Frame
Up to 12 hours
Title
Fluctuation
Description
(Cmax-Cmin)/Cav
Time Frame
Up to 12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Males and females adults aged 20 to 65 years Diagnosed as schizophrenia prior to the screening visit 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: Subjects who have a medical history specified in protocol Subjects with confirmed abnormal laboratory values specified in protocol Subjects who have a medication history or safety risks specified in protocol Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol Subjects who are expected to have the prohibited concomitant medication therapy during the study period Pregnant women or breast-feeding women or men and women who has possibility of pregnancy Subjects who are not suitable for the clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo-Hyun Yoon
Organizational Affiliation
Department of Psychiatry, Naju National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whan In Pharm.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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