title: Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies.
abstract: The bioequivalence of two megestrol acetate formulations, 160-mg "tablets" and 160-mg "sachets," was investigated in a single-dose, open-label, balanced-for-sequence cross-over study involving 12 advanced-cancer patients. The observed plasma megestrol-acetate time course obtained with both formulations was consistent with the literature data. The main source of variability in the pharmacokinetic parameters was intersubject variability; drug formulation played only a minor (and nonsignificant) role. The width of the 90% confidence interval of the area-under-the-curve (AUC) ratio (sachets: tablets) computed according to Schuirmann (0.9-1.4) was mainly due to the presence of a single outlier, showing an AUC ratio of 2.7. The trend to higher bioavailability of the new formulation was not significant, especially as compared with the dose-response data reported in the literature.
authors.affiliation: Dipartimento di Chimica Organica, Università di Bologna, Italy.
authors.forename: C M
authors.initials: CM
authors.lastname: Camaggi
authors.forename: E
authors.initials: E
authors.lastname: Strocchi
authors.forename: A
authors.initials: A
authors.lastname: Martoni
authors.forename: C
authors.initials: C
authors.lastname: Zamagni
authors.forename: N
authors.initials: N
authors.lastname: Cacciari
authors.forename: G
authors.initials: G
authors.lastname: Robustelli della Cuna
authors.forename: L
authors.initials: L
authors.lastname: Pavesi
authors.forename: M
authors.initials: M
authors.lastname: Tedeschi
authors.forename: A
authors.initials: A
authors.lastname: Silva
authors.forename: F
authors.initials: F
authors.lastname: Pannuti
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001682:Biological Availability; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D008535:Megestrol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D019290:Megestrol Acetate; D008875:Middle Aged; D009369:Neoplasms / Q000378:metabolism*; D011208:Powders; D013607:Tablets
chemical_list: D011208:Powders; D013607:Tablets; D008535:Megestrol; D019290:Megestrol Acetate