To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days. Aripiprazole plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
31
an immediate-release tablet containing 10 mg Aripiprazole
an immediate-release tablet containing 10 mg Aripiprazole
Future Research Center (FRC)
Cairo, Egypt
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Aripiprazole peak concentration
Time frame: Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose
Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)
The AUC (0-72h) is the area under the Aripiprazole plasma concentration with time curve from the time of dosing to the 72-hour sample
Time frame: Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose
Maximum time (Tmax)
Time until Cmax is reached
Time frame: Pre-dose (0) and at 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48, 72 hours post dose
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