A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: DWCZP; Clozaril
Intervention description: Multiple dose; multiple-dose
Intervention MeSH terms: Clozapine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  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.