EUCTR2011-000824-14-IT进行中（未招募）不适用
Pharmacokinetics of orally aministered single doses (40-60-80 mcg) of T3 sulfate (T3S)-sodium salt. A single blind, randomized, placebo-controlled clinical study in healthy subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BRACCO
- 入组人数
- 24
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
- •Provided written Informed Consent and willing to comply with protocol requirements •Age between 18 and 40 years •Either sex Healthy subjects•BMI ranging between 20 and 25 Kg/mq for either gender Subjects coming from the scientific community will be preferable.
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of any severe metabolic, organ or systemic disease •Presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study. •History of allergy, sensitivity or intolerance to the study drugs and/or any of the study drugs formulation ingredients •Assumption of any substance affecting thyroid hormone GI absorption or metabolism (soya and soya derivatives, aluminium/iron or calcium carbonate-containing preparations) •Blood-donation within 30 days before admission to this study •Assumption of an investigational compound within 30 days before admission to this study • History of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements •Pregnancy [Exclude the possibility of pregnancy by testing on site at the institution (serum or urine ßHCG; to be retest at Investigator judgement) or by surgical history (e.g., tubal ligation or hysterectomy)]. Menstruated female subject will be strongly recommended to avoid vaginal intercourse starting from signing the Informed Consent until day 5 after dosing. •Breastfeeding •Subjects unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study •Pharmacological treatment ongoing •Skin lesions at the site of the blood sampling •Difficult access to the periferal venous blood vessels •Employees of the investigator or study centre (i.e. principal investigator, co-investigator(s), study coordinators, other study staff, contractors…) with direct involvement in this study or other studies under the direction of the investigator , as well as family members of the employees or the investigator.
研究者
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