SchizophreniaPhase 1DWCZP-I-1NCT01654601
A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
A Phase 1 study testing DWCZP and Clozaril in people with Schizophrenia, run by Dong Wha Pharmaceutical Co. Ltd. at 5 sites in South Korea.
Trial summary
To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- DWCZP and Clozaril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jun 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult male or female within range of 20 to 60.
- Diagnosed as Schizophrenia (Note: Diagnosed with DSM-IV, ICD-10 as a standard Schizophrenia diagnostic tool).
- Administered clozapine for 3 months before signing agreement with same amount daily and who can administer clozapine 100mg twice (morning, evening) a day, total of 200mg during the study time.
- One who might be pregnant must get negative result for pregnancy test (urine or blood β-hCG) before the randomization and during the study time, one must agree appropriate contraception. However, one who is using only hormone-contraceptive for birth control and has not been more that 1 year after Tubal ligation or menopause are excluded.
- One who understood completed about this study after the explanation is given, decided to volunteer and gave written informed consent approved by IRB to participate in study in compliance with the requirement of the entire protocol.
Who cannot join
- One who has record of hypersensitive reaction with Clozapine or other antipsychotic drug.
- WBC count less than 4,000/ml or Absolute Neutrophil count less than 2,000/ml.
- Administering hypertension drug or has orthostatic hypotension.
- One who has clinical problem with kidney or liver and include following criteria: CCr < 50mL/min; BUN > 30 mg/dl; ALT 또는 AST > 3 x ULN; Total bilirubin > 2 x ULN; ALP > 2 x ULN.
- Diagnosed to have other psychiatric or neurological problems other than Schizophrenia (e.g., Organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson's disease, etc).
- Record of Granulocytopenia or Myeloproliferative disorder in the past.
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- Record of stomach-related problems(active Crohn's disease, vital infectious intestine disease, ulcer, acute or chronic pancreatitis etc) or surgery which can affect absorption of study drug. However, simple appendectomy or herniotomy are exceptions.
- Chronic Hepatitis B carrier, proof of Hepatitis C carrier or Hepatitis C antibody.
- Immunodeficiency diseases such as HIV positive, AIDS, had bone marrow transplantation or has blood ammonia.
- Record of seizure in 1 year before signing informed consent form or had administered anti-seizure drug before(e.g., Epilepsy, Convulsions, Myasthenia gravis, etc).
- One who constantly drinks(> 21Units/week, 1Unit = 10g of pure alcohol) or cannot stop drinking alcohol during hospitalization period.
- Smoking past 3 months before signing informed consent form or cannot stop smoking during hospitalization period.
- One who cannot attend routine blood tests.
- Bone marrow malfunction.
- Mental illness, durg addicted or in coma.
- One who has any kind of circulation imperfection and patient with depressed central nervous system.
- Major kidney and heart problem(e.g. myocarditis).
- Incurable epilepsy.
- Paralytic intestinal obstruction.
- Generic problems such as Lactose intolerance, Galactose intolerance, Lapp lactose deficiency, Glucose-Galactose absorption deficiency, etc.
- Administered barbital-related drugs and drug metabolizing enzyme inducer and inhibitor in 1 month before starting the study.
- One who had drugs that can affect on result of the study for past 10 days before the study start.
- One who had whole blood donation in 2 months or blood component donation or transfusion in 1 month before signing the informed consent form.
- Attended clinical tests or bioequivalence tests in 2 months before signing informed consent form.
- Currently pregnant or breast-feeding or has possibility of pregnancy because one is not using medically approved contraception(Note: condoms, oral contraceptive, intrauterine device, abstinence etc).
- One who is clinically significant by observations considered as unsuitable based on medical judgement by investigators.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Konkuk University Hospital
Choongju
Wonkwang University
Iksan
Naju National Hospital
Naju
The Catholic University of Korea, yeouido St.Mary's Hospital
Seoul, 150-896
Seoul National Hospital
Seoul
About this study
Official title: Clinical Trials to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg After a Multi-dose Oral Administration in Schizophrenia Patients
To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.
Read the detailed description
A randomized, 2-way crossover, open, phase I study to compare the pharmacokinetics profile of DWCZP tablet 100mg and Clozaril® tablet 100mg after a multiple-dose oral administration in schizophrenia patients.
- Conditions
- Schizophrenia
- Being tested
- DWCZP, Clozaril
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWCZPDrug
Also called DWCZP Tablet 100mg
Multiple dose
ClozarilDrug
Also called Clozaril Tablet 100mg
multiple-dose
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | 1.1st Administration - DWCZP tablet 100mg Mutiple dose
2.2nd Administration - Clozaril tablet 100mg Mutiple dose Receives: Drug: DWCZP; Drug: Clozaril |
| B Group | Experimental | 1.1st Administration - Clozaril tablet 100mg Mutiple dose
2.2nd Administration - DWCZP tablet 100mg Mutiple dose Receives: Drug: DWCZP; Drug: Clozaril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration of Clozapine in Plasma
Measured: Up to 12hours
Secondary outcomes (3)
Time to Reach Maximum Concentration of Clozapine in Plasma
Measured: Up to 12hours
Terminal Half Life of Clozapine in Plasma
Measured: Up to 12hours
Accumulation Rate of Clozapine in Plasma
Measured: Up tp 12hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Konkuk University Hospital, Naju National Hospital, Seoul National Hospital, Wonkwang University, DongGuk University
- Responsible party
- Sponsor
- Investigators
- Won-Myoung Bahk, M.D., Principal investigator, The Catholic University of Korea, Yeouido St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654601
- Sponsor's protocol ID
- DWCZP-I-1
- Acronym
- DWCZP-I-1
- Status last verified
- Feb 2017
- First submitted
- 25 Jul 2012
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg After a Multi-dose Oral Administration in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT01654601
- Acronym / sponsor ID
- DWCZP-I-1 / DWCZP-I-1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of Korea, Konkuk University Hospital, Naju National Hospital, Seoul National Hospital, Wonkwang University, DongGuk University
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.
Detailed description
A randomized, 2-way crossover, open, phase I study to compare the pharmacokinetics profile of DWCZP tablet 100mg and Clozaril® tablet 100mg after a multiple-dose 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 |
|---|---|---|
| A Group | Experimental | Drug: DWCZP, Drug: Clozaril1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose |
| B Group | Experimental | Drug: DWCZP, Drug: Clozaril1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult male or female within range of 20 to 60.
- Diagnosed as Schizophrenia (Note: Diagnosed with DSM-IV, ICD-10 as a standard Schizophrenia diagnostic tool).
- Administered clozapine for 3 months before signing agreement with same amount daily and who can administer clozapine 100mg twice (morning, evening) a day, total of 200mg during the study time.
- One who might be pregnant must get negative result for pregnancy test (urine or blood β-hCG) before the randomization and during the study time, one must agree appropriate contraception. However, one who is using only hormone-contraceptive for birth control and has not been more that 1 year after Tubal ligation or menopause are excluded.
- One who understood completed about this study after the explanation is given, decided to volunteer and gave written informed consent approved by IRB to participate in study in compliance with the requirement of the entire protocol.
Key exclusion criteria (26 listed)
- One who has record of hypersensitive reaction with Clozapine or other antipsychotic drug.
- WBC count less than 4,000/ml or Absolute Neutrophil count less than 2,000/ml.
- Administering hypertension drug or has orthostatic hypotension.
- One who has clinical problem with kidney or liver and include following criteria: CCr < 50mL/min; BUN > 30 mg/dl; ALT 또는 AST > 3 x ULN; Total bilirubin > 2 x ULN; ALP > 2 x ULN.
- Diagnosed to have other psychiatric or neurological problems other than Schizophrenia (e.g., Organic mental disorder, severe tardive dyskinesia, idiopathic Parkinson's disease, etc).
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 |
|---|---|---|
| DWCZPAlso: DWCZP Tablet 100mgMultiple dose | Drug | A Group, B Group |
| ClozarilAlso: Clozaril Tablet 100mgmultiple-dose | Drug | A Group, B Group |
Primary outcome
Maximum Concentration of Clozapine in Plasma
Time frame: Up to 12hours
3 secondary outcomes
Time to Reach Maximum Concentration of Clozapine in Plasma
Time frame: Up to 12hours
Terminal Half Life of Clozapine in Plasma
Time frame: Up to 12hours
Accumulation Rate of Clozapine in Plasma
Time frame: Up tp 12hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Catholic University of Korea, Yeouido St.Mary's HospitalLink provided by the sponsor.
- Konkuk University HospitalLink provided by the sponsor.
- Naju National HospitalLink provided by the sponsor.
- Seoul National HospitalLink provided by the sponsor.
- Wonkwang UniversityLink provided by the sponsor.
- Dongguk UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Won-Myoung Bahk, M.D. principal investigator
The Catholic University of Korea, Yeouido St.Mary's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWCZP and Clozaril in people with Schizophrenia, run by Dong Wha Pharmaceutical Co. Ltd. at 5 sites 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?
The sponsor lists 5 inclusion and 26 exclusion criteria. 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Concentration of Clozapine in Plasma (time frame: Up to 12hours). 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 27 Mar 2017.