Study On Pharmacokinetics And Bioavailability Of Bisoprolol Fumarate In Human

OBJECTIVE: To study the pharmacokinetics and the relative bioavailability ofbisoprolol tablet in healthy male volunteers.METHOD: An analytical method for the determination of pharmacokineticsand bioavailability of bisoprolol in human plasma has been developed based onliquid chromatography–tandem mass spectrometry. Two tablet formulations ofbisoprolol have been administered to 20 healthy male volunteers, respectively.Pharmacokinetic parameters were determined by standard noncompartmentalmethods.RESULTS: Pharmacokinetic parameters were Cmax 46.76 ± 14.79 and 46.59 ±12.02 ng/mL, Tmax 3.08 ± 1.73 and 2.88 ± 1.88 h, t1/2 8.72 ± 1.16 and 9.13 ±1.23 h, AUC0-t 586.73 ± 179.62 and 602.00 ± 161.20 ng?h/mL, andAUC0-∞601.62 ± 188.61and 618.84 ± 166.04 ng?h/mL for Test and Referenceformulations, respectively. The 90% confidence interval of Cmax(88.11~110.43%), AUC0?t (86.32~107.22%) and AUC0?∞ (85.98~106.75%) werefound within FDA acceptance range of 80-125%.CONCLUSION: It is concluded that the test formulation is bioequivalent tothe reference formulation.