Pharmacokinetic properties of tramadol sustained release capsules - 3rd communication: Investigation of relative bioavailability under steady state conditions

In an open, randomized two-period crossover study in 24 healthy male volunt eers multiple doses of tramadol (CAS 27203-92-5) test and reference medicat ion were administered as follows: Test: sustained release capsules containi ng 100 mg tramadol hydrochloride, a total of 6 capsules at intervals of 12 h; Reference: instant release capsules containing 50 mg tramadol hydrochlor ide, a total of 12 capsules at intervals of 6 h. As a result of the statist ical analysis of AUC((58-72 h))(ss) after logarithmic transformation a bioa vailability of 100% for the sustained release capsules compared with the in stant release capsules was obtained. As expected statistical analysis of th e peak trough fluctuation at steady state PTF(48-72 h)ss yielded a distinct diminution of the fluctuation.