| Literature DB >> 7628056 |
C M Camaggi1, E Strocchi, A Martoni, C Zamagni, N Cacciari, G Robustelli della Cuna, L Pavesi, M Tedeschi, A Silva, F Pannuti.
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.Entities:
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Year: 1995 PMID： 7628056 DOI： 10.1007/BF00689055
Source DB: PubMed Journal: Cancer Chemother Pharmacol ISSN： 0344-5704 Impact factor: 3.333