The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E in the population was also evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Oral
Oral
Unnamed facility
Kyushu, Japan
Maximum plasma concentration (Cmax) of unchanged quetiapine
Time frame: For 48 hours after dosing.
AUC (area under the curve) of unchanged quetiapine
Time frame: For 48 hours after dosing.
tmax of plasma concentration of unchanged quetiapine
Time frame: For 48 hours after dosing.
t1/2 of plasma concentration of unchanged quetiapine
Time frame: For 48 hours after dosing.
Maximum plasma concentration (Cmax) of quetiapine metabolites
Time frame: For 48 hours after dosing.
AUC (area under the curve) of quetiapine metabolites
Time frame: For 48 hours after dosing.
tmax of plasma concentration of quetiapine metabolites
Time frame: For 48 hours after dosing.
t1/2 of plasma concentration of quetiapine metabolites
Time frame: For 48 hours after dosing.
Maximum plasma concentration (Cmax) of unchanged fluvoxamine
Time frame: For 12 hours after dosing.
AUC (area under the curve) of unchanged fluvoxamine
Time frame: For 12 hours after dosing.
tmax of plasma concentration of unchanged fluvoxamine
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Time frame: For 12 hours after dosing.
t1/2 of plasma concentration of unchanged fluvoxamine
Time frame: For 12 hours after dosing.
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
Time frame: Up to 20 Days.