58483
document
Comparative in vitro dissolution and in vivo bioavailability of diflunisal/naproxen fixed-dose combination tablets and concomitant administration of diflunisal and naproxen in healthy adult subjects . A simple validated high-performance liquid chromatography ( HPLC ) assay was developed for determination of diflunisal and naproxen in human plasma samples . This is to compare the bioavailability of diflunisal-naproxen fixed-dose combination ( FDC ) with their separate dosage forms . The in vitro dissolution study was adopted to compare the dissolution behavior of FDC with respect to separate marketed tablets . In vivo study was conducted according to a single-center , randomized , single-dose , laboratory-blinded , 2 Way , Cross-Over Study with a washout period of 10 days . Under fasting conditions , 24 healthy Egyptian male volunteers were randomly allocated to receive a single oral dose of either one FDC tablet or co-administration of two separate diflunisal and naproxen marketed tablets . Plasma samples were obtained over a 72-h interval and analyzed for diflunisal and naproxen by reversed phase liquid chromatography with UV detection . The pharmacokinetic parameters Cmax , AUC0-t , AUC0-∞ , tmax , and t1/2 were determined from plasma concentration-time profiles . The 90 % confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUCt-∞ of the 2 treatments were within the acceptable range ( 0.8-1.25 ) for bioequivalence . From pharmacokinetic and in vitro studies perspectives , 1 FDC tablet demonstrated similar relative bioavailability with the 2 individual -reference tablets .
58484
Intervention_Pharmacological
randomly allocated to receive a single oral dose of either one FDC tablet
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Intervention_Pharmacological
co-administration of two separate diflunisal and naproxen marketed tablets
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Outcome_Physical
bioavailability of diflunisal-naproxen fixed-dose combination ( FDC )
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Outcome_Physical
dissolution behavior of FDC
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Outcome_Physical
diflunisal and naproxen