PHARMACOKINETICS OF AMOXICILLIN DURING PREGNANCY AND POSTPARTUM

阿莫西林在妊娠期和产后的药代动力学

• 批准号: 7379324
• 负责人: MARY F HEBERT
• 金额: $ 0.99万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379324
• 关键词: PHARMACOKINETICS; AMOXICILLIN; DURING; PREGNANCY; POSTPARTUM

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pregnant women are considered an "orphan" population for drug development. Even for drugs commonly administered to pregnant women, such as amoxicillin, there is very limited information available on the pharmacokinetics (PK) of the drug during pregnancy as compared to postpartum. During the recent anthrax scare in Washington DC, there were many individuals exposed or potentially exposed to anthrax spores who received antibiotic prophylaxis. Some of these individuals were pregnant. Because of the lack of information on the PK of amoxicillin during pregnancy and the expected increased elimination of drugs (such as amoxicillin) eliminated by the kidneys during pregnancy, physicians can only guess at the appropriate dose to use. The purpose of this study is to evaluate the pharmacokinetics of amoxicillin during pregnancy and postpartum. We will give healthy pregnant women a single oral dose of amoxicillin (500 mg) during the second (18-22 weeks gestation) and third (30-34 weeks gestation) trimesters of pregnancy and 3 months postpartum. Blood and urine samples will be collected throughout the study days. Healthy pregnant women prior to 18 weeks gestation will be recruited for this study.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。孕妇被认为是药物开发的“孤儿”群体。即使对于孕妇常用的药物（例如阿莫西林），与产后相比，妊娠期间药物的药代动力学（PK）信息也非常有限。在最近华盛顿的炭疽恐慌中，有许多人暴露于或可能暴露于炭疽孢子，他们接受了抗生素预防。其中一些人怀孕了。由于缺乏关于妊娠期间阿莫西林PK的信息，以及妊娠期间通过肾脏消除的药物（如阿莫西林）的预期消除增加，医生只能猜测使用的适当剂量。本研究的目的是评价阿莫西林在妊娠期和产后的药代动力学。我们将在妊娠第二个三个月（妊娠18-22周）和第三个三个月（妊娠30-34周）以及产后3个月给予健康孕妇单次口服阿莫西林（500 mg）。将在整个研究日采集血液和尿液样本。本研究将招募妊娠18周前的健康妊娠女性。