Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01509456
Eligibility Criteria:
Inclusion Criteria:
* healthy male subjects
* age: 20- 45
* weight 65- 85 kg
* height: 158- 190 cm
* BMI 20- 26 kg/m2
* no high performance sports
* non- smoking (minimum 6 months prior to study start)
* willing to complete both parts of the study
* presentation of social security and criminal record
* successful completion of medical and psychological screening
* signed informed consent
Exclusion Criteria:
* drugs- and alcohol abuse
* antiinflammatory drugs taken during the study
* vegetarianism, veganism
* migraine
* psychical illness in the past
* claustrophobia
* hiatal hernia
* gastroesophageal reflux
* diabetes mellitus
* Rheumatic disease
* muscle or joint disease
* disc prolapse
* orthostatic intolerance
* Hyperlipidaemia
* renal disease
* thyroid dysfunction
* hyperhomocysteinaemia
* hyper-/hypouremia
* hyper-/hypocalcemia
* anaemia
* hypoferremia
* Vitamin D deficiency
* deviation of blood gases from normal values (pH 7,38 - 7,42; pO2 79 - 98 mmHg; pCO2 34 - 45 mmHg; HCO3 20 - 28 mmol/l; Base excess ± 2 mmol/l)
* risk of thrombosis
* chronic back pain
* bone fracture within one year prior to study start
* bone mineral density 1,5 SD ≤ t-Score
* metal implants or other osteosynthesis material
* subject within another clinical trial within 2 months prior to study start
* any other status which according to the apprehension of the principal investigator leads to the exclusion of the subject
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01509456
Study Brief:
Protocol Section:
NCT01509456