Bioequivalence Study in Patients With Schizophrenia by Us... | NCT04849026

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

NCT04849026

Sponsor

Whanin Pharmaceutical Company

Status

Completed

Last Update Posted

May 16, 2023Actual

Enrollment

33Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

Clozaril 100 mg (Clozapine)
WID-CLZ18

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2021Actual

Primary Completion Date

Aug 14, 2022Actual

Completion Date

Aug 14, 2022Actual

First Submitted Date

Apr 14, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Period 1: WID-CLZ18 Period 2: Clozaril 100 mg (Clozapine)	Drug: Clozaril 100 mg (Clozapine) Drug: WID-CLZ18
Group B	Experimental	Period 1: Clozaril 100 mg (Clozapine) Period 2: WID-CLZ18	Drug: Clozaril 100 mg (Clozapine) Drug: WID-CLZ18

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clozaril 100 mg (Clozapine)	Drug	2 Doses/Day for 10 days	Group A Group B

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Tmax	Time to maximum blood concentration	Up to 12 hours
T1/2	Terminal elimination half life	Up to 12 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo-Hyun Yoon	Department of Psychiatry, Naju National Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Whan In Pharm.		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003024	Clozapine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided