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

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.

Completed

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Key information

Conditions

Pharmacokinetics

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit, University of Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levothyroxine

Drug

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

Sanofi-Synthelabo

Registry information

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Nov 7, 2011
Registry last updated: Nov 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed