This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
2 Doses/Day for 10 days
2 Doses/Day for 10 days
Whan In Pharm.
Seoul, South Korea
Cmax
Maximum blood concentration in steady state
Time frame: Up to 12 hours
AUC0-12
Area under the concentration-time curve from zero to 12 hours at steady state
Time frame: Up to 12 hours
Tmax
Time to maximum blood concentration
Time frame: Up to 12 hours
T1/2
Terminal elimination half life
Time frame: Up to 12 hours
R
Accumulation rate
Time frame: Up to 12 hours
Cmin
Steady-state peak plasma concentration
Time frame: Up to 12 hours
Fluctuation
(Cmax-Cmin)/Cav
Time frame: Up to 12 hours
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