EUCTR2012-003677-25-IT进行中（未招募）不适用
Safety and bioavailability of Tirosint(Levothyroxine Sodium) Oral Solutionadministered as single dose with or without waterin hypothyroid patients.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •written informed consent; • hypothyroid patients of both genders, thyroidectomized in consequence of thyroid cancer or other thyroid diseases; • =18 and =75 years of age; • Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 • Tg levels < 5 ng/mL; • nondetectable (<30 IU/mL) anti-thyroglobulin antibodies (Tg- Ab); • substitutive and/or TSH suppressive treatment with LT4 tablets at a stable (at least three months) dosage (100 µg/day); • serum FT4, FT3 and TSH within normal values for the patient; • availability and possibility of taking part in the study; • reasonable assumption of understanding the study and of reliability.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •seriously compromised cardiac (heart failure), hepatic, renal and/or respiratory functions; • active arrhythmia or history of arrhythmia, particularly atrial fibrillation • serious metabolic (e.g. uncompensated diabetes mellitus), organs (e.g. cirrhosis of the liver), endocrine or systemic diseases (excluding the basic pathology); • epilepsy; • neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology); • terminal condition; • parenteral or assisted enteral feeding;clinically significant illness or surgery within 4 weeks prior to dosing; • 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; • serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient’s reliability; • non-therapeutic use of psychotropic substances; • alcoholism; • positive test for hepatitis B, hepatitis C, or HIV at screening; • positive pregnancy test; • breast-feeding; • known hypersensitivity to the ingredients of the preparation involved in the study; • use of concomitant medications that might interfere with study evaluations; • regular consumption of soya and soya derivatives • skin lesions at the site of the blood sampling (forearm); • difficult access to the peripheral venous blood vessels; • emesis episode within 24 hours prior to dosing; • participation in other clinical studies during the two months prior to dosing; • donation of blood during the two months prior to dosing; • presumption of poor reliability/cooperation; • any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
研究者
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