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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

NCT ID: NCT01465646

Last Updated: 2011-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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with idodine

Group Type ACTIVE_COMPARATOR

levothyroxine

Intervention Type DRUG

without iodine

Group Type EXPERIMENTAL

levothyroxine

Intervention Type DRUG

Interventions

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levothyroxine

Intervention Type DRUG

levothyroxine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Gerd Mikus

Head of Clinical Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Research Unit, University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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K069-2

Identifier Type: -

Identifier Source: org_study_id