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: 14.1 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: TIROSINT*OS 30FL 1ML 100MCG/ML
Pharmaceutical Form: Oral solution
INN or Proposed INN: LEVOTIROXINA
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
IBSA INSTITUT BIOCHIMIQUE SA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the absorption pattern of LT4, on the basis of circulating total T4 (TT4), in hypothyroid patients already treated with levothyroxine tablets, following the administration of levothyroxine sodium oral solution (LT4s) swallowed in fasting conditions with or without water.;Secondary Objective: To confirm the clinical safety (in terms of vital signs, ECG, adverse events) of the LT4 solution in both administration conditions; to verify the acceptability of the LT4 solution in both administration conditions.;Primary end point(s): To evaluate the absorption pattern of LT4, on the basis of circulating total T4 (TT4), in hypothyroid patients already treated with levothyroxine tablets, following the administration of levothyroxine sodium oral solution (LT4s) swallowed in fasting conditions with or without water.;Timepoint(s) of evaluation of this end point: Blood samples: -0.1 hours (= 6 minutes) pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 24 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To confirm the clinical safety (in terms of vital signs, ECG, adverse events) of the LT4 solution in both administration conditions; to verify the acceptability of the LT4 solution in both administration conditions.;Timepoint(s) of evaluation of this end point: pre-dose and and 24 hours post-dose | — |
Countries
Italy
Contacts
Public ContactClinical Reserarch Manager
IBSA INSTITUT BIOCHIMIQUE SA
Outcome results
None listed