Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi Pharmaceuticals, Egypt under license from: Merck \& Co. Inc., USA) after a single oral dose administration of each to healthy adults under fasting conditions.
19 blood samples will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the whole study.0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50, 3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours post dose. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Genuine Research Center GRC
Cairo, Egypt
Maximal measured plasma concentration (Cmax)
Serial blood samples for determination of study drug will be collected pre-dose and at 0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50, 3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours postdose
Time frame: 24 hours
measurable concentration (t) (AUC [0 to t])
(AUC \[0 to t\]) will be calculated by the linear trapezoidal method.
Time frame: 24 hours
Area Under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity])
AUC (0 to infinity) will be calculated as the sum of the AUC (0 to t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
Time frame: 24 hours
Time of the maximum plasma concentration (tmax)measurable concentration (t) (AUC [0 to t])
If the Tmax occurs at more than time point, then tmax will be considered for the first occurrence..
Time frame: 24 hours
Apparent first-order elimination or terminal rate constant (K¬e)
K¬e will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations
Time frame: 24 hours
Terminal half life (t1/2e)
The elimination or terminal half-life will be calculated as 0.693/ Ke
Time frame: 24 hours
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