The current study is conducted to evaluate and compare the relative bioavailability for Quetiapine in two different products containing 25 mg Quetiapine after a single oral dose administration under fasting conditions.
A randomized, single-dose, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Quetiapine plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
32
Film Coated Tablets products containing 25 mg Quetiapine
Reference product (R) 25 mg Film Coated Tablets
Future Research Center (FRC)
Cairo, Egypt
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Quetiapine peak concentration
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose
Area under the plasma concentration curve from administration to last observed concentration at time t (AUC(0-t))
The AUC (0-t) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast)
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose
Area under the plasma concentration curve extrapolated to infinite time (AUC(0-inf))
AUC(0-inf) "the area under the curve," which is a way of measuring the total amount of the active drug in a subject's system over a period of time from administration ("0") to the time that the drug is no longer present in the subject's body ("infinity")
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose
Maximum time (Tmax)
Time until Cmax is reached
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose
Elimination Rate Constant (Kel)
Kel is a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose
Plasma concentration half-life (t1/2)
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t1/2 is the time taken for the plasma concentration of a drug to reduce to half its original value. It is used to estimate how long it takes for a drug to be removed from your body.
Time frame: Pre-dose (0), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours post dose