Relative bioavailability study of a generic effervescent tablet formulation of dexketoprofen and thiocolchicoside versus the originator 25 mg film coated tablet (dexketoprofen) and 8 mg capsule (thiocolchicoside)

Aims: The aim of this study was to evaluate the pharmacokinetic profiles and relative bioavailability dexketoprofen thiocolchicoside test preparation (dexketoprofen / 25 mg 8 effervescent tablet) in comparison with reference preparations (Keral film coated tablet, containing trometamol equivalent (Menarini International Operations Luxembourg S.A.) (R1) Muscoril capsule, (Sanofi Aventis İlaçları Ltd. Şti.) (R2) under fasting conditions. Methods: healthy male subjects were enrolled study. Volunteers hospitalised from evening before drug administration (Day 0) until after 24-hour blood sampling time on Day 2. Results: 24 completed Relative (AUCT/AUCR1) 100.99 %; (AUCT/AUCR2) 3-O-glucuronide (aglycone) 100.47 (Cmax,T/Cmax,R1) 122.59 (Cmax,T/Cmax,R2) 111.43 %. Conclusions: AUCT /AUCR compared both is comparable, as shown by geometric mean ratios 100.59 % (dexketoprofen) 98.20 (3-O-glucuronide (aglycone).