Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT01465633
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2011-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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: 50 μg/ 75 μg Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2011-11-02', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioavailability', 'levothyroxine'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Euthyroid men\n* Age: 18 - 50\n* Normal values for fT4 und TSH\n* Good state of health\n\nExclusion Criteria:\n\n* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism\n* History of thyroid function disorders\n* Focal or diffuse autonomies of the thyroid gland\n* Thyroid nodules \\>1 ml according to sonographic examination\n* Any acute or chronic illness\n* Dermatitis herpetiformis'}, 'identificationModule': {'nctId': 'NCT01465633', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'K069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'with iodine', 'interventionNames': ['Drug: levothyroxine']}, {'type': 'EXPERIMENTAL', 'label': 'without iodine', 'interventionNames': ['Drug: levothyroxine']}], 'interventions': [{'name': 'levothyroxine', 'type': 'DRUG', 'armGroupLabels': ['with iodine']}, {'name': 'levothyroxine', 'type': 'DRUG', 'armGroupLabels': ['without iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Clinical Research Unit, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi-Synthelabo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinical Research Unit', 'investigatorFullName': 'Gerd Mikus', 'investigatorAffiliation': 'Heidelberg University'}}}}