To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects. To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.
Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo. This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
37
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
Xuhui Center Hospital
Shanghai, Shanghai Municipality, China
Lurasidone Cmax
Cmax:Maximum (peak) observed drug serum concentration.
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC
AUC:Area under the serum concentration-time curve
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Tmax
Tmax:Time to maximum (peak) drug serum concentration
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone λZ
λZ:Elimination rate constant
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone t1/2
t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone MRT
MRT:Mean residence time.
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone CL/F
CL/F:Apparent total clearance.
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone VZ/F
VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)
Time frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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