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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Lack of effect of a high-fat meal on the bioavailability of 17 beta-estradiolorgestimate in healthy postmenopausal women.
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Lack of effect of a high-fat meal on the bioavailability of 17 beta-estradiolorgestimate in healthy postmenopausal women.

机译：在健康的绝经后妇女中，高脂膳食对17β-雌二醇/孕激素的生物利用度缺乏影响。

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摘要

The effect of a high-fat meal on the absorption and pharmacokinetics of 17 beta-estradiol (E2), estrone (E1), estrone sulfate (E1S), and 17-deacetylnorgestimate (17d-NGM) were determined in this two-way complete crossover study of a single dose of E2/NGM (2 mg/180 micrograms) in 24 postmenopausal women. Equal numbers of subjects were randomly assigned to two treatment sequences indicated by the order of fed and fasting treatments. Serial blood samples were collected before and after dosing and assayed using validated methods. Food had no effect on the pharmacokinetics of E2, the pharmacologically active estrogen species. Food increased the rates of formation of E1 and E1S and slowed the formation of 17d-NGM. However, because E1 and E1S are pharmacologically less active metabolites of E2, and since the pharmacokinetic alterations in 17d-NGM were observed over a short time period, these results are probably of no clinical relevance. The extent of formation of all analytes, as measured by AUC, was not affected by food. In conclusion, administration of a tablet containing 17 beta-estradiolorgestimate (2 mg/180 micrograms) was safe and well tolerated by healthy postmenopausal women and may be given without regard to the timing of meals in relation to dosing.
机译：在此双向测定中，确定了高脂膳食对17β-雌二醇（E2），雌酮（E1），硫酸雌酮（E1S）和17-去乙酰基孕育酸酯（17d-NGM）的吸收和药代动力学的影响对24名绝经后妇女进行单剂量E2 / NGM（2 mg / 180微克）的交叉研究。将相等数量的受试者随机分配给两个治疗顺序，分别由进食和禁食的顺序指示。在给药之前和之后收集系列血样，并使用经验证的方法进行分析。食物对具有药理活性的雌激素E2的药代动力学没有影响。食物会增加E1和E1S的形成速度，并减慢17d-NGM的形成。但是，由于E1和E1S是E2的药理活性较弱的代谢物，并且由于在很短的时间内观察到17d-NGM的药代动力学变化，因此这些结果可能与临床无关。通过AUC测量，所有分析物的形成程度不受食物影响。总之，健康绝经后妇女服用含有17种β-雌二醇/孕育激素（2毫克/ 180微克）的片剂是安全且耐受性良好的，并且可以在不考虑就餐时间的情况下服用。

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