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临床试验/EUCTR2013-003418-42-DE
EUCTR2013-003418-42-DE进行中(未招募)1 期

Effect of Mg-Orotate administration on cardiocirculatory Performance, the muscular concentration of phosphocreatine and the adaptation of muscle cellular level: A double blind, randomized, placebo-controlled, cross-over pilot study active ingredients versus placebo for 3 months

Wörwag Pharma GmbH & Co. KG0 个研究点目标入组 12 人开始时间: 2015年4月14日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
12

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 1. Potential volunteer are obliged to be informed in details about the study and the loading results. In the study only included, who afterword signs a dated consent form.
  • 2. Men between 18 and 35 years, which may have a regular workout.
  • 3. No serious internal medical or neurological pre-existing diseases in the history (as judged by the investigator).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 12
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Chronic neurological or internal diseases.
  • 2. Taking medications or food supplements and vitamins within the last 4 weeks.
  • 3. Contraindications for the administration of magnesium orotate (e.g. allergy).
  • 4. Contraindications for the application of local anesthetics (allergy, Hypersensitivity).
  • 5. Participation in a drug trial within the last three months prior to study inclusion.
  • 6. Clinically significant deviation of certain laboratory parameters (Hb <13 g / dl, Deviation of the liver values over twice the normal (ALT, AST, ALP), GFR <60 ml / min, serum electrolytes (Na, K, Mg) in the normal. PT / PTT value outside the normal.
  • 7. Known coagulation disorders.
  • 8. Taking drugs.
  • 9. Venous conditions that do not allow multiple blood draws.

研究者

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