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
- Registration Number
- NCT01465633
- Lead Sponsor
- Heidelberg University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Euthyroid men
- Age: 18 - 50
- Normal values for fT4 und TSH
- Good state of health
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description with iodine levothyroxine - without iodine levothyroxine -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Unit, University of Heidelberg
🇩🇪Heidelberg, Germany