SchizophreniaPhase 1NCT04849026
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
A Phase 1 study testing Clozaril 100 mg (Clozapine) and WID-CLZ18 in people with Schizophrenia, run by Whanin Pharmaceutical Company at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clozaril 100 mg (Clozapine) and WID-CLZ18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2021to 14 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Schizophrenia
- Being tested
- Clozaril 100 mg (Clozapine), WID-CLZ18
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clozaril 100 mg (Clozapine)Drug
2 Doses/Day for 10 days
WID-CLZ18Drug
2 Doses/Day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 1. Period 1: WID-CLZ18
2. Period 2: Clozaril 100 mg (Clozapine) Receives: Drug: Clozaril 100 mg (Clozapine); Drug: WID-CLZ18 |
| Group B | Experimental | 1. Period 1: Clozaril 100 mg (Clozapine)
2. Period 2: WID-CLZ18 Receives: Drug: Clozaril 100 mg (Clozapine); Drug: WID-CLZ18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum blood concentration in steady state
Measured: Up to 12 hours
AUC0-12
Area under the concentration-time curve from zero to 12 hours at steady state
Measured: Up to 12 hours
Secondary outcomes (5)
Tmax
Time to maximum blood concentration
Measured: Up to 12 hours
T1/2
Terminal elimination half life
Measured: Up to 12 hours
R
Accumulation rate
Measured: Up to 12 hours
Cmin
Steady-state peak plasma concentration
Measured: Up to 12 hours
Fluctuation
(Cmax-Cmin)/Cav
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start15 Jan 2021
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Whanin Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo-Hyun Yoon, Principal investigator, Department of Psychiatry, Naju National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849026
- Sponsor's protocol ID
- WID-CLZ18-BE
- Status last verified
- May 2023
- First submitted
- 14 Apr 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04849026
- Acronym / sponsor ID
- WID-CLZ18-BE
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Whanin Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Clozaril 100 mg (Clozapine), Drug: WID-CLZ181. Period 1: WID-CLZ18 2. Period 2: Clozaril 100 mg (Clozapine) |
| Group B | Experimental | Drug: Clozaril 100 mg (Clozapine), Drug: WID-CLZ181. Period 1: Clozaril 100 mg (Clozapine) 2. Period 2: WID-CLZ18 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clozaril 100 mg (Clozapine)2 Doses/Day for 10 days | Drug | Group A, Group B |
| WID-CLZ182 Doses/Day for 10 days | Drug | Group A, Group B |
Primary outcome
Cmax
Time frame: Up to 12 hours
Maximum blood concentration in steady state
AUC0-12
Time frame: Up to 12 hours
Area under the concentration-time curve from zero to 12 hours at steady state
5 secondary outcomes
Tmax
Time frame: Up to 12 hours
T1/2
Time frame: Up to 12 hours
R
Time frame: Up to 12 hours
Cmin
Time frame: Up to 12 hours
Fluctuation
Time frame: Up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo-Hyun Yoon principal investigator
Department of Psychiatry, Naju National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clozaril 100 mg (Clozapine) and WID-CLZ18 in people with Schizophrenia, run by Whanin Pharmaceutical Company at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Up to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.