Studies on pharmacokinetics and relative bioavailability of naproxen

OBJECTIVE To evaluate the bioequivalence of two dosageforms of naproxen. METHODS Single oral dose of naproxen particles and capsule were given to 18 volunteers in an open randomized crossover way to study the pharmacokinetics and relative bioavailability, naproxen concentrations in plasma were determined by HPLC. RESULTS The pharmacokinetic parameters of test and control formulations were as follows: T max ( 1.1 ± 0.6 ) and ( 1.3 ± 0.8 )h; C max ( 36.1 ± 7.6 ) and ( 40.6 ± 8.9 ) mg·L -1 ; t 1/2 ( 15.9 ± 2.5 ) and ( 15.5 ± 2.2 )h; AUC 0～t ( 499.6 ± 118.2 ) and ( 539.9 ± 126.9 ) mg·h·L -1 ; AUC 0→∞ ( 559.5 ± 132.4 ) and ( 667.2 ± 155.6 ) mg·h·L -1 . The relative bioavailability of test formulation was ( 94.8 ± 13.1 )%. The result of statistical analysis on above parameters showed that there was no significant difference between two formulations. CONCLUSIONS The two formulations were bioequivalent.