Comparative bioavailability of diclofenac hydroxyethylpyrrolidine vs diclofenac sodium in man.
A phamacokinetic study in man has been made of a new dosage form of diclofenac hydroxyethylpyrrolidine (DIEP); soluble salt packed in sachets was compared with diclofenac sodium as enteric coated tablets. Oral DIEP 2 X 50 mg showed a significant difference in absorption kinetics (ka, lag time and tmax) as compared to oral diclofenac sodium 2 X 50 mg. A relevant plasma concentration of diclofenac was detected just 15 min after DIEP, while diclofenac sodium produced a measurable plasma concentration only 0.5-1 h after the treatment. Cmax and t1/2 after DIEP and diclofenac sodium were comparable. Comparison of the two AUC values showed that DIEP was bioequivalent to diclofenac sodium (Q = 100%).
Maggi
C A
CA
Ospedale Costantino Cantu, Abbiategrasso, Italy.
Lualdi
P
P
Mautone
G
G
D001682:Biological Availability; D004008:Diclofenac / Q000031:analogs & derivatives* / Q000493:pharmacokinetics* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
C064142:diclofenac hydroxyethylpyrrolidine; D004008:Diclofenac