Pharmacokinetics and Relative Bioequivalence of Single and Multiple Oral Doses of Ibuprofen Sustained-Release Capsules

The pharmacokinetics and bioequivalence of two brands of ibuprofen sustained-release capsules was investigated in 20 healthy male volunteers, according to randomized crossover design. The concentrations of ibuprofen in plasma were determined by LC-MS method. The pharmacokinetic parameters for the single oral administration of 300mg test and reference capsules were Cmax (19.21±3.49) and (16.86±4.30)μg/ml, tmax(5.00±0.73) and (4.85±0.67) h, t1/2(2.45 ±0.52) and (3.42±1.17)h, respectively. The relative bioavailability of test capsules was (101.74±10.52 )%. The pharmacokinetic parameters for the multiple oral administration of 300mg test and reference capsules were Cmax (17.58± 4.38) and (14.46±3.61)μg/ml, tmax(4.68±1.13) and (4.68±1.46)h,DF (176.05±32.33) and (138.00±25.55)%, t1/2(3.01±0.77) and (3.60±0.82)h, respectively. The relative bioavailability of test capsules was (99.09±11.13)%. The results showed that the test and reference preparations were bioequivalence.