[A bioequivalence study in man of tablet and capsule formulations of the nonsteroidal anti-inflammatory compound 2-methoxyphenyl 1-methyl-5-(p-methylbenzoylpyrrol)-2-acetamidoacetate].
ST-679.(2-methoxyphenyl 1-methyl-5p-methylbenzoyl pyrrole-2-acetamide acetate) is a novel non-steroid anti-inflammatory agent consisting of tolmetin linked by an amide link to guaiacole-esterified glycine. The above reported study was aimed at to evaluation and comparison of pharmacokinetic parameters (Tmax, Cmax, AUC, t1/2 beta) of TGA, tolmetin, and MCPA in healthy volunteers after a single oral 600 mg tablet or capsule of ST-679 in order to assess the bioequivalence of the two formulations. The findings obtained show that pharmacokinetic parameters after administration of a 600 mg tablet are comparable to those after a 600 mg capsule. The two formulations may therefore be considered bioequivalent.
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*; D002214:Capsules; D005260:Female; D005998:Glycine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; 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; D002214:Capsules; 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 capsule del composto antinfiammatorio non steroideo 2-metossifenil 1-metil 5 p-metilbenzoilpirrol-2acetamide acetato.