Absorption of oral lornoxicam in healthy volunteers using a granular formulation in comparison with standard tablets.
The bioavailability of lornoxicam (CAS 70374-39-9), a novel highly potent anti-inflammatory and analgesic agent, was studied in healthy volunteers after single doses of a new oral formulation (8 mg granules) in comparison to tablets (8 mg). Eighteen healthy volunteers (6 males and 12 females) with a mean age of 29.4 were given a single 8 mg dose of each formulation in an open, cross-over study, with randomised sequences. Lornoxicam plasma levels were determined by an HPLC method. Cmax, AUC0-infinity and t 1/2 beta values were similar for both the granules and tablets, but tmax and lag time values after lornoxicam granules were significantly shorter than after the tablets. During the study, no side-effects were noted with either of the formulations studied. Therefore this study showed that lornoxicam granular formulation had a faster absorption than tablets even though the two formulations can be considered bioequivalent.
Bareggi
S R
SR
Department of Pharmacology, Medical School, University of Milan, Italy.
Gambaro
V
V
Valenti
M
M
Benvenuti
C
C
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D001682:Biological Availability; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010894:Piroxicam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013607:Tablets
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D010894:Piroxicam; C059451:lornoxicam