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

Information source: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: DWCZP (Drug); Clozaril (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dong Wha Pharmaceutical Co. Ltd.

Official(s) and/or principal investigator(s):
Won-Myoung Bahk, M.D., Principal Investigator, Affiliation: The Catholic University of Korea


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Maximum Concentration of Clozapine in Plasma

Secondary outcome:

Time to Reach Maximum Concentration of Clozapine in Plasma

Terminal Half Life of Clozapine in Plasma

Accumulation Rate of Clozapine in Plasma

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.


Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Konkuk University Hospital, Choongju, Korea, Republic of

Wonkwang University, Iksan, Korea, Republic of

Naju National Hospital, Naju, Korea, Republic of

Seoul National Hospital, Seoul, Korea, Republic of

The Catholic University of Korea, yeouido St.Mary's Hospital, Seoul 150-896, Korea, Republic of

Additional Information

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

Konkuk University Hospital

Naju National Hospital

Seoul National Hospital

Wonkwang University

Dongguk University

Starting date: June 2012
Last updated: February 13, 2014

Page last updated: August 20, 2015

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