Bioavailability Investigations of Thyronajod Mite Tablets... | NCT01465646

Studies
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

NCT01465646

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Nov 7, 2011Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

levothyroxine
levothyroxine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief 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: 100 μg/ 75 μg Tablets

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Nov 2, 2011

First Submission Date that Met QC Criteria

Nov 4, 2011

First Posted Date

Nov 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2011

Last Update Posted Date

Nov 7, 2011Estimated

Name	Class
Sanofi-Synthelabo	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with idodine	Active Comparator		Drug: levothyroxine
without iodine	Experimental		Drug: levothyroxine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levothyroxine	Drug		with idodine
levothyroxine

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Unit, University of Heidelberg		Heidelberg		69120	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins