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
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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