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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:
ClinicalTrials.gov Identifier:
NCT01465646
First Posted: November 7, 2011
Last Update Posted: November 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Gerd Mikus, University of Heidelberg
  Purpose
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.

Condition Intervention Phase
Pharmacokinetics Drug: levothyroxine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Gerd Mikus, University of Heidelberg:

Enrollment: 24
Study Start Date: June 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with idodine Drug: levothyroxine
Experimental: without iodine Drug: levothyroxine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465646


Locations
Germany
Clinical Research Unit, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Sanofi-Synthelabo
  More Information

Responsible Party: Gerd Mikus, Head of Clinical Research Unit, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01465646     History of Changes
Other Study ID Numbers: K069-2
First Submitted: November 2, 2011
First Posted: November 7, 2011
Last Update Posted: November 7, 2011
Last Verified: November 2011

Keywords provided by Gerd Mikus, University of Heidelberg:
levothyroxine
bioavailability