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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.
Information provided by (Responsible Party):
Gerd Mikus, University of Heidelberg Identifier:
First received: November 2, 2011
Last updated: November 4, 2011
Last verified: November 2011
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01465646

Clinical Research Unit, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
  More Information

Responsible Party: Gerd Mikus, Head of Clinical Research Unit, University of Heidelberg Identifier: NCT01465646     History of Changes
Other Study ID Numbers: K069-2
Study First Received: November 2, 2011
Last Updated: November 4, 2011

Keywords provided by Gerd Mikus, University of Heidelberg:
bioavailability processed this record on August 17, 2017