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

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

Looking for future studies?

Notify Me

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

Interested in participating?

Completed

Looking for future studies?

Notify Me

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