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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465646

Enrollment

Registered

2011-11-07

Start date

2003-06-30

Completion date

2003-12-31

Last updated

2011-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

levothyroxine, bioavailability

Brief summary

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.

Interventions

DRUGlevothyroxine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026