To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Etoricoxib 90 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 14 days. Etoricoxib 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
30
an immediate-release tablet containing 90 mg of Etoricoxib
an immediate-release tablet containing 90 mg of Etoricoxib
Future Research Center (FRC)
Cairo, Egypt
Maximum plasma concentration (Cmax)
Cmax is observed at the maximum of Etoricoxib peak concentration
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
the area under the curve (AUC 0-t)
Cumulative Area Under the Etoricoxib plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
the area under the curve extrapolated to infinity (AUC0-∞)
AUC from Dosing time extrapolated to infinity, based on the last observed concentration
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Maximum time (Tmax)
Time until Cmax is reached
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent terminal half-life (t½)
the time required for the Etoricoxib plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent elimination rate constant (Kel).
First-order rate constant associated with the terminal (log-linear) portion of the curve
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.