Comparative bioavailability study of two ibuprofen preparations after oral administration in healthy volunteers.
The bioavailability of a new ibuprofen (2-(p-isobutylphenyl)propionic acid, CAS 15687-27-1) preparation was compared with a reference preparation of the drug in 23 healthy male volunteers, aged between 19 and 27. A single dose of 400 mg was given orally in the fasted state, using a randomized two-way crossover study. A washout period of two weeks separated both treatment periods. Ibuprofen plasma levels were determined by means of a validated HPLC method (UV detector). Values of 154.48 +/- 53.27 microg x h/ml (95 % confidence interval CI: 133.50-177.03) for the test, and 140.86 +/- 44.82 microg x h/ml (95% CI: 122.53-159.16) for the reference preparation AUC(0-infinity) demonstrate a nearly identical extent of drug absorption. Maximum plasma concentrations Cmax of 39.53 +/- 7.11 microg/ml (95 % CI: 35.97-41.78) and 37.71 +/- 8.67 microg/ml (95% CI: 33.37-40.46) achieved for the test and reference preparations did not differ significantly. AUC(0-infinity) and Cmax ratios (90% CI) were within the 80-125% interval required for bioequivalence as stipulated in the current international regulations of the European Agency for the Evalution of Medicinal Products and the Food and Drug Administration. Therefore it is concluded that the new ibuprofen preparation is therapeutically equivalent to the reference preparation for both, the extent and the rate of absorption, after single dose administration in healthy volunteers.
Bienert
Agnieszka
A
Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, Karol Marcinkowski University of Medical Sciences, Poznań, Poland. agnbienert@op.pl
Szkutnik-Fiedler
Danuta
D
Dyderski
Stanisław
S
Grześkowiak
Edmund
E
Drobnik
Leon
L
Wolc
Anna
A
Slawińiska
Urszula
U
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics* / Q000633:toxicity*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D007052:Ibuprofen / Q000493:pharmacokinetics* / Q000633:toxicity*; D008297:Male; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013608:Tablets, Enteric-Coated
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D013608:Tablets, Enteric-Coated; D007052:Ibuprofen