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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 2011
Last Updated Date	November 4, 2011
Start Date ^ICMJE	June 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01465646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Pharmacokinetics
Intervention ^ICMJE	Drug: levothyroxine
Study Arm (s)	Active Comparator: with idodine Intervention: Drug: levothyroxine Experimental: without iodine Intervention: Drug: levothyroxine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	December 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01465646
Other Study ID Numbers ^ICMJE	K069-2
Has Data Monitoring Committee	No
Responsible Party	Gerd Mikus, University of Heidelberg
Study Sponsor ^ICMJE	University of Heidelberg
Collaborators ^ICMJE	Sanofi-Synthelabo
Investigators ^ICMJE	Not Provided
Information Provided By	University of Heidelberg
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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