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: 50 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:
NCT01465633
First received: November 2, 2011
Last updated: November 4, 2011
Last verified: November 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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: 50 μg/ 75 μg Tablets

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465633

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

No publications provided

Responsible Party: Gerd Mikus, Head of Clinical Research Unit, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01465633     History of Changes
Other Study ID Numbers: K069
Study First Received: November 2, 2011
Last Updated: November 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
bioavailability
levothyroxine

Additional relevant MeSH terms:
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014