This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.
The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. The safety of FK949E in the population is also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Oral
Unnamed facility
Kanto, Japan
Maximum plasma concentration (Cmax) of unchanged quetiapine
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
AUC24h (area under the curve for 24hr) of unchanged quetiapine
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
Trough value of plasma concentration of unchanged quetiapine
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
t1/2 of plasma concentration of unchanged quetiapine
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
Maximum plasma concentration (Cmax) of quetiapine metabolites
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
AUC (area under the curve) of quetiapine metabolites
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
trough value of plasma concentration of quetiapine metabolites
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
tmax of plasma concentration of quetiapine metabolites
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 hours after dosing
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t1/2 of plasma concentration of quetiapine metabolites
Frequent blood sampling on Day 6 and Day 10
Time frame: For 24 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 Day 11