safety of the administration of levothyroxine sodiumoral solution (LT4s) swallowed in fasting conditions with or withoutwater in hypothyroid patients

• Conditions: Therapeutic area: Diseases [C] - Hormonal diseases [C19]; Both genders thyroidectomized patients, with thyroglobulin (Tg) circulating levels below 5 ng/mL and no evidence of Tg antibodies (Tg-Ab), at stable (at least 3 months) 100 µg/day levothyroxine tablets therapy; MedDRA version: 14.1Level: PTClassification code 10021114Term: HypothyroidismSystem Organ Class: 10014698 - Endocrine disorders

• Registration Number: EUCTR2012-003677-25-IT
• Lead Sponsor: IBSA INSTITUT BIOCHIMIQUE SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-28
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• written informed consent; • hypothyroid patients of both genders, thyroidectomized in consequence of thyroid cancer or other thyroid diseases; • =18 and =75 years of age; • Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 • Tg levels < 5 ng/mL; • nondetectable (<30 IU/mL) anti-thyroglobulin antibodies (Tg- Ab); • substitutive and/or TSH suppressive treatment with LT4 tablets at a stable (at least three months) dosage (100 µg/day); • serum FT4, FT3 and TSH within normal values for the patient; • availability and possibility of taking part in the study; • reasonable assumption of understanding the study and of reliability.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

seriously compromised cardiac (heart failure), hepatic, renal and/or respiratory functions; • active arrhythmia or history of arrhythmia, particularly atrial fibrillation • serious metabolic (e.g. uncompensated diabetes mellitus), organs (e.g. cirrhosis of the liver), endocrine or systemic diseases (excluding the basic pathology); • epilepsy; • neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology); • terminal condition; • parenteral or assisted enteral feeding;clinically significant illness or surgery within 4 weeks prior to dosing; • presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study; • serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient’s reliability; • non-therapeutic use of psychotropic substances; • alcoholism; • positive test for hepatitis B, hepatitis C, or HIV at screening; • positive pregnancy test; • breast-feeding; • known hypersensitivity to the ingredients of the preparation involved in the study; • use of concomitant medications that might interfere with study evaluations; • regular consumption of soya and soya derivatives • skin lesions at the site of the blood sampling (forearm); • difficult access to the peripheral venous blood vessels; • emesis episode within 24 hours prior to dosing; • participation in other clinical studies during the two months prior to dosing; • donation of blood during the two months prior to dosing; • presumption of poor reliability/cooperation; • any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified