To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Aripiprazole 3 mg/sertraline 100 mg combination drug
Aripiprazole 3 mg and sertraline 100 mg
Clinic of Kyusyu Region
Fukuoka, Japan
Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Cmax of Aripiprazole and Sertraline in Cohort 2
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
AUC168h of Aripiprazole and Sertraline in Cohort 2
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
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