Status:
COMPLETED
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: 100 μg/ 75 μg Tablets
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 fr...
Eligibility Criteria
Inclusion
- Euthyroid men
- Age: 18 - 50
- Normal values for fT4 und TSH
- Good state of health
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01465646
Start Date
June 1 2003
End Date
December 1 2003
Last Update
November 7 2011
Active Locations (1)
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1
Clinical Research Unit, University of Heidelberg
Heidelberg, Germany, 69120