Evaluation of two new megestrol acetate tablet formulations in humans
作者:
R. C. Gaver,
K. A. Pittman,
C. M. Reilly,
P. J. Goodson,
G. O. Breault,
E. Fenzl,
期刊:
Biopharmaceutics&Drug Disposition
(WILEY Available online 1986)
卷期:
Volume 7,
issue 1
页码: 35-46
ISSN:0142-2782
年代: 1986
DOI:10.1002/bdd.2510070106
出版商: John Wiley&Sons, Ltd.
关键词: Bioequivalence;Megestrol acetate;Megace®;Tablets
数据来源: WILEY
摘要:
AbstractThe bioequivalence of two new investigational 160 mg tablets, one containing the regular form and the other a micronized form of megestrol acetate, was determined relative to a commercially available 40 mg tablet (Megace®). The tablets were administered to 24 male subjects in a three‐way cross‐over study, balanced for sequence, with a week between administrations. The 40 mg tablets were administered q.i.d. at 08.00, 12.00, 18.00 and 22.00 h, while the 160 mg tablets were administered once at 08.00 h. Plasma samples were collected at appropriate times out to 96 h after administration and were analysed for megestrol acetate with a validated high performance liquid chromatographic procedure. Based on the times to maximum plasma concentrations (2·5 to 2·8 h), the absorption rate constant was the same for each of the tablets. Relative to the 40 mg q.i.d. dose, the 160 mg regular and the 160 mg micronized tablets had mean relative bioavailabilities of 97 per cent and 118 per cent, respec
点击下载:
PDF
(548KB)
返 回