Clinical trial NCT01654601: A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Catholic University of Korea
name: Konkuk University Hospital
name: Naju National Hospital
name: Seoul National Hospital
name: Wonkwang University
name: DongGuk University
First posted: 2012-08-01
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Maximum Concentration of Clozapine in Plasma
timeFrame: Up to 12hours
Secondary outcomes:
measure: Time to Reach Maximum Concentration of Clozapine in Plasma
timeFrame: Up to 12hours
measure: Terminal Half Life of Clozapine in Plasma
timeFrame: Up to 12hours
measure: Accumulation Rate of Clozapine in Plasma
timeFrame: Up tp 12hours
Other outcomes:
Locations:
city: Choongju
country: Korea, Republic of
facility: Konkuk University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University
city: Naju
country: Korea, Republic of
facility: Naju National Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, yeouido St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
affiliation: The Catholic University of Korea, Yeouido St.Mary's Hospital
name: Won-Myoung Bahk, M.D.
role: PRINCIPAL_INVESTIGATOR
References: