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 areaunder-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 doseresponse data reported in the literature.
| Original language | English |
|---|---|
| Pages (from-to) | 356-359 |
| Number of pages | 4 |
| Journal | Cancer Chemotherapy and Pharmacology |
| Volume | 36 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Jul 1995 |
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Keywords
- Bioequivalence
- Megestrol acetate
- Pharmacokinetics
ASJC Scopus subject areas
- Pharmacology
- Oncology
- Cancer Research
Cite this
Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies. / Camaggi, C. M.; Strocchi, E.; Martoni, A.; Zamagni, C.; Cacciari, N.; Robustelli della Cuna, G.; Pavesi, L.; Tedeschi, M.; Silva, A.; Pannuti, F.
In: Cancer Chemotherapy and Pharmacology, Vol. 36, No. 4, 07.1995, p. 356-359.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies
AU - Camaggi, C. M.
AU - Strocchi, E.
AU - Martoni, A.
AU - Zamagni, C.
AU - Cacciari, N.
AU - Robustelli della Cuna, G.
AU - Pavesi, L.
AU - Tedeschi, M.
AU - Silva, A.
AU - Pannuti, F.
PY - 1995/7
Y1 - 1995/7
N2 - 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 areaunder-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 doseresponse data reported in the literature.
AB - 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 areaunder-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 doseresponse data reported in the literature.
KW - Bioequivalence
KW - Megestrol acetate
KW - Pharmacokinetics
UR - http://www.scopus.com/inward/record.url?scp=0029019018&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029019018&partnerID=8YFLogxK
U2 - 10.1007/BF00689055
DO - 10.1007/BF00689055
M3 - Article
C2 - 7628056
AN - SCOPUS:0029019018
VL - 36
SP - 356
EP - 359
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 4
ER -