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 tm...

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Veröffentlicht in:European journal of clinical pharmacology 1990-01, Vol.38 (2), p.207-208
Hauptverfasser: MAGGI, C. A, LUALDI, P, MAUTONE, G
Format: Artikel
Sprache:eng
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Zusammenfassung: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%).
ISSN:0031-6970
1432-1041
DOI:10.1007/BF00265987