EUCTR2014-000563-41-ES进行中（未招募）不适用
Recombinant hGH Biomarkers Discovery - REBIODIS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- All
入选标准
- •- Healthy male and females volunteers aged from 18 to 30 years, both ages included.
- •- Caucasian and non-Caucasian individuals (Europeans, Africans, Asians, Indians).
- •- Body mass index (BMI) between 19 and 26 Kg/m2, and weight between 50 and 90 kg.
- •- Subjects with high level of physical training including regular high-resistance strength training, training at least 5 hours a week or an expenditure of energy of about 5000 kcal a week.
- •- A health profile devoid of organic or physiological disorders.
- •- Pass the review based on medical history, physical examination and clinical laboratory tests.
- •- Understand and accept the trial procedures.
- •- Signature of the written informed consent to participate.
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Non compliance of the inclusion criteria.
- •- Prior or current history of consumption of addictive substances (except nicotine). Smokers of more than 10 cigarettes / day should be excluded.
- •Have some organic disease or major surgery in the 3 months prior to the start the study.
- •- Suffer any kind of disease, acute or chronic, at the moment of the study.
- •- Regular consumers of medications that contain any of the following substances: steroids, erythropoietin (EPO), growth hormone (hGH), insulin-like growth factor-1 (IGF-1), diuretics and plasma expanders. Intake of beta blockers and glucocorticoids in asthmatics is accepted. Other medication will be accepted depending on the Principal Investigator criteria, as flu containing ephedrines.
- •- A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with absorption, distribution, metabolism, or excretion of the drug administered in the study. If the subjects will be at risk as decided by the Investigator.
- •- Suffer any kind of bone or connective tissues injuries in the last 3 months.
- •- A significant psychiatric disorder, alcoholism, substance abuse or dependence (except for nicotine, criteria defined above), or consumption of psychoactive drugs.
- •- Alcohol consumption over 15 grams per day in men and 10 grams per day in women.
- •- Caffeine or another drinks specified like drinking > 3 cups of coffee and tea per day, drinking > 3 units of coke, stimulants or equivalent per day, in the 2 months prior to the study.
- •- Have used a medication regularly in the last month previous to the start of the study. Other type of medication may be allowed, depending on the Investigator.
- •- To be blood donor or have taken part in studies with blood donation in the last 4 weeks prior to the study.
- •- History of allergy or adverse reactions to any medication.
- •- Have been a volunteer in another study with drugs in the last 3 months prior to start this study.
- •- Subjects for whom the drug involved in the study is counter indicated.
- •- Subjects with positive serology for hepatitis B, C or HIV.
- •- Women with pregnancy or in the breast-feeding period or that are taking contraception treatment during the period of the study.
- •- Subjects that not have capacity to understand the nature, consequences of the study or the procedures requested to follow.
研究者
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