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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01820702
Eligibility Criteria:
Inclusion Criteria:
* • Healthy male test subjects, aged between 20 and 45 years old with a Body Mass Index (BMI) of 20 - 26 kg/m2 and a height of 158 - 190 cm (62 - 75 inches)
* 65 - 85 kg
* Not a competitive athlete
* Non-smoker, for at least six months before the start of the study
* In the position to participate in the complete study
* Demonstrable social insurance and official certificate of absence of criminal record
* Successful completion of screening examination
* Provision of Declaration on Consent at the start of the study
Exclusion Criteria:
* • Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
* Smoking
* Vegetarian, vegan
* Migraine
* Previous psychiatric illness
* Claustrophobia
* Hiatus hernia
* Gastro-oesophageal reflux
* Diabetes mellitus
* Rheumatic illness
* Muscle or joint disorder
* Prolapse of intervertebral disk
* Pronounced orthostatic intolerance
* Hyperlipidaemia (deviations from standard values, standard values: TG \< 180 mg/dl, cumulative CH \< 200 mg/dl, HDL \> 35 mg/dl, LDL \< 160 mg/dl)
* Renal dysfunction (deviation from plasma creatinin standard values, standard value \< 1.20 mg/dl)
* Thyroid dysfunction (deviation from standard values for plasma TSH, standard value TSH 0.27 - 4.20 U/l)
* Hyperhomocysteinemia (deviation from standard value for plasma homocysteine, standard value homocysteine \>15 µmol/l)
* Hyper-, Hypouricemia (deviation from plasma uric acid standard values, age dependent standard value 3.0-6.9 mg/dl)
* Hyper-, Hypocalcemia (deviation from plasma calcium standard values, age dependent standard value 2.15-2.64 mmol/l)
* Anaemia: (\< as standard values for plasma haemoglobin, standard values for men 13.5-17.5 g/dl)
* Iron deficiency: ferritin \< 30 µg/l
* Vitamin D deficiency: D3-25-OH \< 50 ng/ml
* Blood gas values deviating from the normal values:
* pH 7.38-7.42
* pCO2 34-45 mmHg
* pO2 79-98 mmHg
* HCO3 20-28 mmol/l
* Base deviation ± 2 mmol/l
* Family history of thrombosis or positive response in thrombosis screening procedure: Biochemical analysis of the following parameter: ATIII, protein C and S activities, factor V Leiden, prothrombin mutants, lupus PTT
* Chronic back complaints
* Bone fracture in the year preceding the study
* Bone density of the femur and lower spine (L1-L4) 1.5 SD ≤ t-score
* Metal implants or other kinds of bone synthesis materials
* Participation in another clinical study within the last 2 months before start of this study
* Imprisoned at the time of the study
* Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the examiner
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01820702
Study Brief:
Protocol Section:
NCT01820702