Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg (NCT NCT01654601)
NCT ID: NCT01654601
Last Updated: 2017-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Up to 12hours
Results posted on
2017-03-27
Participant Flow
Participants recruited from a specialty clinic at s hospital, in Seoul, Naju, Chungju, Iksan and Kyungju, Korea between June 2012 and March 2013
32 participantsrecruited : 28 screened, 4 excluded(3 did not meet inclusion criteria and 1 refused participation)
Participant milestones
| Measure |
A Group
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
1st Administration
STARTED
|
14
|
14
|
|
1st Administration
COMPLETED
|
12
|
12
|
|
1st Administration
NOT COMPLETED
|
2
|
2
|
|
2nd Administration
STARTED
|
12
|
12
|
|
2nd Administration
COMPLETED
|
11
|
11
|
|
2nd Administration
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
A Group
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
1st Administration
Withdrawal by Subject
|
2
|
0
|
|
1st Administration
Protocol Violation
|
0
|
2
|
|
2nd Administration
Adverse Event
|
1
|
0
|
|
2nd Administration
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
Baseline characteristics by cohort
| Measure |
A Group
n=14 Participants
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
n=14 Participants
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12hoursOutcome measures
| Measure |
A Group
n=11 Participants
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
n=11 Participants
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
Maximum Concentration of Clozapine in Plasma
|
524.62 ng/mL
Standard Deviation 272.51
|
551.18 ng/mL
Standard Deviation 263.26
|
SECONDARY outcome
Timeframe: Up to 12hoursOutcome measures
| Measure |
A Group
n=11 Participants
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
n=11 Participants
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
Time to Reach Maximum Concentration of Clozapine in Plasma
|
2.43 hour
Standard Deviation 1.71
|
2.75 hour
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Up to 12hoursOutcome measures
| Measure |
A Group
n=11 Participants
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
n=11 Participants
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
Terminal Half Life of Clozapine in Plasma
|
11.98 hour
Standard Deviation 6.89
|
10.88 hour
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: Up tp 12hoursOutcome measures
| Measure |
A Group
n=11 Participants
DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
B Group
n=11 Participants
Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
|
|---|---|---|
|
Accumulation Rate of Clozapine in Plasma
|
2.01 ng/ml/hr
Standard Deviation 0.81
|
1.88 ng/ml/hr
Standard Deviation 0.44
|
Adverse Events
A Group
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
B Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A Group
n=14 participants at risk
1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
|
B Group
n=14 participants at risk
1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture of distal clavicle, Lt.
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
Other adverse events
| Measure |
A Group
n=14 participants at risk
1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
|
B Group
n=14 participants at risk
1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
General disorders
Pyrexia
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Eye disorders
Ocular discomfort
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Psychiatric disorders
Apathy
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Reproductive system and breast disorders
Dysmenorthoea
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
7.1%
1/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
0.00%
0/14 • 3 weeks
abnormal vital sign, physical examination, electrocardiogram or laboratory finding after study drug adminstration
|
Additional Information
Won-myung Bahk. M.D. PhD.
The Catholic university of Korea
Phone: 82-2-3779-1051
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place