Comparison of pharmacokinetics and relative bioavailability of two types of naproxen in healthy volunteers

Objective: To study pharmacokinetics and relative bioavailability of naproxen tablets in healthy volunteers.Methods: A single oral 500mg dose of Bei Shi naproxen(NAPB) tablets and Lian Bang naproxen(NAPL) tablets were given to 20 healthy volunteers in an open randomized crossover study. Naproxen concentration in serum was determined by HPLC. The pharmacokinetic parameters as well as relative bioavailability were measured.Results:The concentration-time curves of NAPB tablets and NAPL tablets were conformed to a two compartment open model.The t1/2β were (17.10±9.39)h and (16.97±6.73)h, Cmax (134.49±22.12) μg/ml and (129.08±26.74) μg/ml, Tmax(2.10±0.64)h and (1.88±0.70)h , AUC(0～72) (1810.57±400.60) μ g·h/ml and (1762.53±347.94)μ g·h/ml, respectively. There was no significant difference between the two formulations in the AUC(0～72), Cmax, Tmax. Conclusion: The relative bioavailability of NAPB tablets was (102.72±13.76)% compared with NAPL tablets.The result of the statistical analysis showed that the two formations were bioequivalent.