000			02504nam a2200181Ia 4500
005			20151005140011.0
008			150525s2011 xx 000 0 und d
041			_aeng
082			_a1311,T
100			_aSadia Amin _97820
110			_cDr. Sualeha Riffat _97821
245			_aBioequivalence Study Of Montelukast Tablets In Healthy Volunteets
260			_c2011
502			_aObjective of this bioequivalence study was to compare pharmacokinetic parameters and to evaluate bioequivalence of two generic drug products. A multinational company brand was compared with locally manufacture brand. It was a randomized, single dose, two-period crossover study in which 12 volunteers were participated with the age limit of 18-30yrs. These volunteers were selected according to different inclusion and exclusion criteria and the study was conducted with one week washout period. Each volunteer was one tablet of montelukast (reference or test) lOmg. 14 blood samples of 4-Sml collected at predefined time intervals i.e, 0, O.S, 1.0, 1.S, 2.0, 2.5, 3.0, 3.S, 4.0, 6.0, 8.0, 10, 12 and 24 hours .. Heparinized vacuette were used for collection of blood samples. After sampling, blood samples were centrifuged immediately to separate plasma and stored at -80°C till analyzed. Plasma montelukast concentration was evaluated by using reverse phase - high performance liquid chromatography (RP-HPLC) method. Potassium dihydrogen phosphate O.OSM at pH 3.5 with orthophosphoric acid in combination to acetonitrile (20:80) was used as mobile phase. The wavelength of detector was set at 34Snm and flow rate was set to 2.0ml per min. Drug from plasma was extracted by de-proteinizing the plasma with acetonitrile. 70 III injection volume was given to HPLC for analysis. For comparing the pharmacokinetic parameters two compartment analysis was used and pair t-test was applied. Non compartmental analysis was used for evaluating pharmacokinetic parameters to evaluate the both drugs were bioequivalent or not. 3 major parameters of bioequivalence Cmax, AVC O-inf and AVC O-t were evaluated and they did not show significant difference in between two formulations. Also the 90% confidence interval values were within the limit. So, it was concluded that both the test and reference drug were bioequivalent and test drug could be used interchangeably with the reference drug.
650			_aDepartment of Pharmaoclogy & Toxicology _95037
700			_aProf. Dr. Muhammad Ashraf _95038
942			_cTH
999			_c3027 _d3027