- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01465633
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
November 4, 2011 updated by: Gerd Mikus, Heidelberg University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Heidelberg, Germany, 69120
- Clinical Research Unit, University of Heidelberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: without iodine
|
|
Active Comparator: with iodine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
November 1, 2003
Study Completion (Actual)
November 1, 2003
Study Registration Dates
First Submitted
November 2, 2011
First Submitted That Met QC Criteria
November 4, 2011
First Posted (Estimate)
November 6, 2011
Study Record Updates
Last Update Posted (Estimate)
November 6, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- K069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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