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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

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Gerd Mikus, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01465646
First received: November 2, 2011
Last updated: November 4, 2011
Last verified: November 2011

November 2, 2011
November 4, 2011
June 2003
December 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01465646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pharmacokinetics
Drug: levothyroxine
  • Active Comparator: with idodine
    Intervention: Drug: levothyroxine
  • Experimental: without iodine
    Intervention: Drug: levothyroxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2003
December 2003   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01465646
K069-2
No
Gerd Mikus, University of Heidelberg
Heidelberg University
Sanofi-Synthelabo
Not Provided
Heidelberg University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP