[A bioequivalence study of tablet and powder formulations of the nonsteroidal anti-inflammatory drug 2-methoxyphenyl 1-methyl-5-(p-methylbenzoylpyrrol)-2-acetamidoacetate].
The purpose of the current study was that of evaluating and comparing the pharmacokinetic parameters (Tmax, Cmax, Ke, AUC, t1/2 beta) at the compounds TGA, tolmetin and MCPA obtained from healthy volunteers following a single oral administration of 600 mg of 2-methoxyphenyl 1-methyl 5 p-methylbenzoylpyrrole-2acetamide acetate (ST-679, previously called MED-15) in the form of tablets and envelopes in order to establish the bioequivalence of the above-mentioned preparations. The results obtained indicate that the administration of 600 mg of 2 methoxyphenyl 1-methyl 5 p-methylbenzoylpyrrole-2acetamide acetate (ST-679) tablets produces from a pharmacokinetics point of view, in man, pharmacokinetic parameters comparable to those obtained following administration of the same dose of the drug in envelopes. It is, therefore, possible to affirm that the preparation of 2-methoxyphenyl 1-methyl 5-p-methylbenzoylpyrrole-2acetamide acetate (ST-679) in envelopes is bioequivalent to that of the tablets.
Annunziato
L
L
Facoltà di Medicina e Chirurgia, Cattedra di Farmacologia, Università degli Studi G. D'Annunzio di Chieti.
di Renzo
G
G
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D005998:Glycine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D011208:Powders; D011758:Pyrroles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D013997:Time Factors; D014046:Tolmetin / Q000031:analogs & derivatives / Q000493:pharmacokinetics
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011208:Powders; D011758:Pyrroles; D013607:Tablets; C065762:ST 679; C020402:1-methyl-5-(4-carboxybenzoyl)-1H-pyrrole-2-acetic acid; C058077:tolmetin glycinamide; D014046:Tolmetin; D005998:Glycine
Studio della bioequivalenza nell'uomo delle preparazioni in compresse ed in bustine del farmaco antinfiammatorio non steroideo 2-metossifenil 1-metil 5 p-metilbenzoilpirrol-2acetamide acetato.