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A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg (DWCZP-I-1)

This study has been completed.
Sponsor:
Collaborators:
The Catholic University of Korea
Konkuk University Hospital
Naju National Hospital
Seoul National Hospital
Wonkwang University
DongGuk University
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01654601
First received: July 25, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: DWCZP
Drug: Clozaril
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Dong Wha Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • Maximum Concentration of Clozapine in Plasma [ Time Frame: Up to 12hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Reach Maximum Concentration of Clozapine in Plasma [ Time Frame: Up to 12hours ] [ Designated as safety issue: Yes ]
  • Terminal Half Life of Clozapine in Plasma [ Time Frame: Up to 12hours ] [ Designated as safety issue: Yes ]
  • Accumulation Rate of Clozapine in Plasma [ Time Frame: Up tp 12hours ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Group

1.1st Administration - DWCZP tablet 100mg Mutiple dose

2.2nd Administration - Clozaril tablet 100mg Mutiple dose

Drug: DWCZP
Multiple dose
Other Name: DWCZP Tablet 100mg
Drug: Clozaril
multiple-dose
Other Name: Clozaril Tablet 100mg
Experimental: B Group

1.1st Administration - Clozaril tablet 100mg Mutiple dose

2.2nd Administration - DWCZP tablet 100mg Mutiple dose

Drug: DWCZP
Multiple dose
Other Name: DWCZP Tablet 100mg
Drug: Clozaril
multiple-dose
Other Name: Clozaril 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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654601

Locations
Korea, Republic of
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, Korea, Republic of, 150-896
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
The Catholic University of Korea
Konkuk University Hospital
Naju National Hospital
Seoul National Hospital
Wonkwang University
DongGuk University
Investigators
Principal Investigator: Won-Myoung Bahk, M.D. The Catholic University of Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01654601     History of Changes
Other Study ID Numbers: DWCZP-I-1
Study First Received: July 25, 2012
Results First Received: December 17, 2013
Last Updated: February 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Clozapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014