Steady state disposition of 5-aminosalicyclic acid following oral dosing.
In 18 healthy volunteers the steady state disposition of 5-aminosalicylic acid (5-ASA, mesalazine, CAS 89-57-6; 500 mg tid) was evaluated following the last oral dose in form of slow release tablets (Salofalk) either containing 500 mg or 250 mg 5-ASA. In none of the pharmacokinetic parameters of 5-ASA characterizing bioavailability (e.g. AUC approximately 6 ug/ml x h; Cmax approximately 1.7 micrograms/ml; tmax approximately 5 h; Cminss approximately 0.5 micrograms/ml; Cavss approximately 0.75 microgram/ml) differences between both forms were observed and the calculated 90% confidence intervals and point estimates indicated bioequivalence. Following the delayed absorption 5-ASA was rapidly eliminated (t1/2 = 1.4 +/- 0.5 h).
Klotz
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U
Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Fed. Rep. of Germany.
Stracciari
G L
GL
D000284:Administration, Oral; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D019804:Mesalamine; D013050:Spectrometry, Fluorescence
D000636:Aminosalicylic Acids; D019804:Mesalamine