To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 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. Fluoxetine plasma concentrations were 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
34
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
an immediate release hard gelatin capsule containing Fluoxetine hydrochloride equivalent to Fluoxetine 10 mg
Future Research Center (FRC)
Cairo, Egypt
Maximum plasma concentration (Cmax)
Cmax is observed as the maximum of Fluoxetine peak concentration
Time frame: (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Truncated area under the plasma concentration curve from administration to last observed (AUC 0-72h)
The AUC (0-72h) is the area under the Fluoxetine plasma concentration with time curve from the time of dosing to the 72-hour sample
Time frame: (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
Maximum time (Tmax)
Time until Cmax is reached
Time frame: (Pre-dose) and at 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 24, 36, 48 and 72 hours
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