Effect of the magnesium salt that combines the mode of action of magnesium and orotic acid (vitamin B13”) on muscle fibers during training adaptations

Phase 1

Conditions: Evaluation of cardiocirculatory performance using clinical and relevant muscle laboratory parameters while taking Mg-Orotate and application of workouts
Therapeutic area: Health Care [N] - Environment and Public Health [N06]

Registration Number: EUCTR2013-003418-42-DE

Lead Sponsor: Wörwag Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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.