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人用微粉型和超微粉型灰黄霉素制剂的相对生物利用度

Comparative bioavailability of a microsize and ultramicrosize griseofulvin formulation in man.

作者信息

Lin C, Lim J, DiGiore C, Gural R, Symchowicz S

出版信息

J Int Med Res. 1982;10(4):274-7. doi: 10.1177/030006058201000415.

Abstract

The bioavailability of 500 mg of a microsize formulation of griseofulvin has been compared to two new ultramicrosize griseofulvin formulations, two 165 mg tablets and a 330 mg tablet, in sixteen healthy, male, volunteers in a randomized crossover study design. Based on the griseofulvin plasma levels measured at specified times over a 48-hour period, the major bioavailability parameters (i.e., area under plasma concentration-time curve, maximum plasma concentration, and time to reach maximum plasma concentration) were determined and statistically evaluated. The results showed that one 330 mg ultramicrosize tablet is bioequivalent to two 165 mg ultramicrosize griseofulvin tablets and that either ultramicrosize griseofulvin dosage regimen is bioequivalent to 500 mg of the microsize griseofulvin formulation.

摘要

在一项随机交叉研究设计中,对16名健康男性志愿者比较了500毫克微晶型灰黄霉素制剂与两种新型超微晶型灰黄霉素制剂、两片165毫克片剂和一片330毫克片剂的生物利用度。根据在48小时内特定时间测量的灰黄霉素血浆水平,确定并统计评估了主要生物利用度参数(即血浆浓度-时间曲线下面积、最大血浆浓度和达到最大血浆浓度的时间)。结果表明,一片330毫克超微晶型片剂与两片165毫克超微晶型灰黄霉素片剂生物等效,且两种超微晶型灰黄霉素给药方案均与500毫克微晶型灰黄霉素制剂生物等效。

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