当前位置： SCI文献检索 > JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS期刊下所有文献 > A phase I trial assessing the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of single-dose Auron Misheil therapy in healthy male subjects.

A phase I trial assessing the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of single-dose Auron Misheil therapy in healthy male subjects.

Abstract：

BACKGROUND AND OBJECTIVE:Auron Misheil therapy (AMT) is a combination of widely used pharmaceuticals and herbal components that has been used since the 1980s as a supportive therapy, mainly in end-stage cancer patients on a compassionate basis. This phase I study was conducted to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of AMT in a controlled trial environment. METHODS:The study was conducted in a single rising dose, double-blind, placebo-controlled design. Three groups of eight healthy male volunteers received one of three doses of AMT (0·011, 0·033 or 0·066 mL AMT/kg body weight intramuscularly; n = 6 per group) or placebo (n = 2 per group). RESULTS AND DISCUSSION:Auron Misheil therapy was shown to be well tolerated, revealing no severe or serious adverse events. There were no unexpected PK or PD results for any of the three components of AMT. CONCLUSIONS:These data provide important PK, PD and safety data for AMT, and support further controlled clinical investigation in patients with different types of cancer as an option for supportive care.

journal_name

J Clin Pharm Ther

journal_title

Journal of clinical pharmacy and therapeutics

authors

Scheele J,Diergarten K,Drevs J,Niazi FR

doi

10.1111/j.1365-2710.2009.01087.x

subject

Has Abstract

pub_date

2013-02-01 00:00:00

pages

3-11

issue

1

eissn

0269-4727

issn

1365-2710

journal_volume

38

pub_type

杂志文章

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