EUCTR2010-023918-30-IT进行中（未招募）不适用
Pilot clinical study on the systemic bioavailability of l-thyroxine in healthy female volunteers after four weeks of topical treatment with a new formulation based on l-thyroxine - SOMA-001-2010
SOCIETA' ITALO BRITANNICA L. MANETTI - H.ROBERTS & C. PER AZIONI0 个研究点目标入组 20 人开始时间: 2012年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- Female
入选标准
- •1. Adult women aged between 18 and 50 years.
- •2. Caucasians.
- •3. BMI (Body Mass Index) <30.
- •4. Blood pressure, measured in the supine position after 5 minutes rest, less than or equal to 90 mm / Hg and 140 mm / Hg respectively for systolic and diastolic.
- •5. Heart rate measured in the supine position after 5 minutes of rest between 50 and 90 beats / minute.
- •6. Signing the informed consent form.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy or breast-feeding in place.
- •2. Changes (early or suspension) of the use of contraceptive estrogen-progestin in the last 4 weeks.
- •3. Inability to take adequate contraception during the study.
- •4. Any disease or dysfunction, even asymptomatic, significant endocrine disruption and thyroid in particular.
- •5. Any acute or chronic detectable load of any device on history.
- •6. Any clinically significant abnormality detected on examination.
- •7. Any clinically significant abnormality detectable on ECG.
- •8. Any clinically significant abnormal laboratory values.
- •9. History of allergy or intolerance to study the products and / or excipients.
- •10. Over the past 6 months, treatment or therapeutic use of iodine or iodine-containing medications (eg amiodarone, Somatoline).
- •11. Over the past 6 months, treatment with antithyroid drugs.
- •12. Over the past 6 months, diagnostic tests that led to the use of tracers, contrast agents containing iodine or iodine isotopes.
- •13. During the past 4 weeks, changes in diet of foods containing iodine (eg iodized salt), or use disinfectants (eg Betadine), detergents or any systemic or topical product containing iodine, including mouthwashes (eg Iodosan), toothpaste iodinated, douches, Lugol's solution.
- •14. Alcohol abuse (over 75 g / day of ethanol), xanthine (over 5 cups / day), tobacco (over 10 cigarettes / day) or use of psychotropic drugs (except for occasional use as ipnoinuttori) or any drug.
- •15. Donate blood or bleeding in the previous three months, or intentions to donate blood during the study and 4 weeks later.
- •16. Persons unable to psychological or linguistic reasons, to understand the information given to obtain the consent or who refuse to give consent in writing.
- •17. Another clinical study in the four weeks prior to or during this study or are planning to take part in a study with experimental drugs during the current surve
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