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A PHASE II RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE STEADY STATE PHARMACOK

A PHASE II RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE STEADY STATE PHARMACOK
比较稳态 PHARMACOK 的 II 期随机交叉研究
批准号:
7606205
负责人:
CHRISTINA C. WANG
金额:
$0.72万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-02-01 至 2007-11-30

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中文摘要
翻译
这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可以在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 这项研究的目的是看看有多少睾丸激素(男性激素)仍然在血液中在不同的时间后,治疗两种不同剂量的睾酮洗剂(睾酮计量剂量(MD)-洗剂<$).这些实验剂量的睾酮MD洗剂尚未被美国食品和药物管理局批准用于患者。 两种剂量的睾酮乳液中的每一种都将装在一个装有泵的瓶子里,每天将乳液涂在腋窝上。 以前的研究表明,这种睾酮乳液适用于腋窝增加和维持(保持恒定)体内的睾酮水平。在本研究中,您将在7天内接受两次剂量的睾酮洗剂(30或60 mg)。 研究药物(特氟沙星计量剂量(MD)-洗剂)由Acrux Pharma Pty.有限公司、澳大利亚,赞助这项研究的公司。
英文摘要
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. The purpose of this research study is to see how much testosterone (male hormone) remains in the blood at different times after treatment with two different doses of testosterone lotion (Testosterone Metered Dose (MD) -Lotion¿). These experimental doses of testosterone MD lotion have not been approved by the U.S. Food and Drug Administration for use in patients. Each of the two doses of testosterone lotion will be in a bottle fitted with a pump and the lotion is applied daily to the armpits. Previous studies have shown that this testosterone lotion applied to the armpits increase and maintain (keep constant) the levels of testosterone in the body. You will receive the two doses of testosterone lotion (30 or 60 mg) over a period of 7 days for each dose in this study. The study drug (Testosterone Metered Dose (MD) -Lotion¿) is made and will be provided by Acrux Pharma Pty. Ltd., Australia, the company that is sponsoring this study.
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