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

Heidelberg University

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: levothyroxine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01465633

K069

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

with iodine

Active Comparator group

Treatment:

Drug: levothyroxine

Drug: levothyroxine

without iodine

Experimental group

Treatment:

Drug: levothyroxine

Drug: levothyroxine