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NCT01465633 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01465633
Other study ID # K069
Secondary ID
Status Completed
Phase Phase 1
First received November 2, 2011
Last updated November 4, 2011
Start date August 2003
Est. completion date November 2003

Study information
Verified date November 2011
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date November 2003
Est. primary completion date November 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• levothyroxine

• levothyroxine

Locations
Country Name City State
Germany Clinical Research Unit, University of Heidelberg Heidelberg

Sponsors (2)
Lead Sponsor Collaborator
Heidelberg University Sanofi-Synthelabo

Country where clinical trial is conducted

Germany, 

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