A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg

NCT01654601 | Completed Phase 1 Results

• 1 other identifier: DWCZP-I-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Maximum Concentration of Clozapine in Plasma

  Up to 12hours

Secondary Outcomes (3)

• Time to Reach Maximum Concentration of Clozapine in Plasma

  Up to 12hours

• Terminal Half Life of Clozapine in Plasma

  Up to 12hours

• Accumulation Rate of Clozapine in Plasma

  Up tp 12hours

Study Arms (2)

A Group

EXPERIMENTAL

1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose

Drug: DWCZP; Drug: Clozaril

B Group

EXPERIMENTAL

1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose

Drug: DWCZP; Drug: Clozaril

Interventions

DWCZP DRUG

Multiple dose

Also known as: DWCZP Tablet 100mg

A Group; B Group

Clozaril DRUG

multiple-dose

Also known as: Clozaril Tablet 100mg

A Group; B Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead
• The Catholic University of Korea: collaborator
• Konkuk University Hospital: collaborator
• Naju National Hospital: collaborator
• Seoul National Hospital: collaborator
• Wonkwang University: collaborator
• DongGuk University: collaborator

Study Sites (5)

Konkuk University Hospital

Choongju, South Korea

Location

Wonkwang University

Iksan, South Korea

Location

Naju National Hospital

Naju, South Korea

Location

The Catholic University of Korea, yeouido St.Mary's Hospital

Seoul, 150-896, South Korea

Location

Seoul National Hospital

Seoul, South Korea

Location

Related Links

• The Catholic University of Korea, Yeouido St.Mary's Hospital
• Konkuk University Hospital
• Naju National Hospital
• Seoul National Hospital
• Wonkwang University
• Dongguk University

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Won-myung Bahk. M.D. PhD.
• Organization: The Catholic university of Korea

wmbahk@catholic.ac.kr

82-2-3779-1051

Study Officials

• Won-Myoung Bahk, M.D.

  The Catholic University of Korea, Yeouido St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: August 1, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 27, 2017
• Results First Posted: March 14, 2014

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)