NCT01465633已完成1 期
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Euthyroid men
- •Age: 18 - 50
- •Normal values for fT4 und TSH
- •Good state of health
排除标准
- •Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
- •History of thyroid function disorders
- •Focal or diffuse autonomies of the thyroid gland
- •Thyroid nodules >1 ml according to sonographic examination
- •Any acute or chronic illness
- •Dermatitis herpetiformis
研究组 & 干预措施
with iodine
Active Comparator
干预措施: levothyroxine (Drug)
without iodine
Experimental
干预措施: levothyroxine (Drug)
研究者
Gerd Mikus
Head of Clinical Research Unit
Heidelberg University
研究点 (1)
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