![]() ![]() Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. As well, some forms of this medication may not be used for all of the conditions discussed here. This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. Levothyroxine may also be used in addition to surgery and radioactive iodine treatment to treat certain types of thyroid cancer. This medication is also used to decrease the size of an enlarged thyroid gland, also known as goiter. It may take several weeks for this medication to have a noticeable effect on your condition. Levothyroxine helps to reduce the symptoms of low thyroid hormone such as weight gain, sensitivity to cold, lack of energy, and dry skin. Levothyroxine is a thyroid hormone supplement for people who do not produce enough thyroid hormone on their own. Volunteers with clinically significant allergies to food, medication, etc.How does this medication work? What will it do for me?.Volunteers on a special diet in the last 28 days (eg vegetarian diet, etc.).Volunteers who do not avoid the intake of coffee, tea, grapefruit, cola and / or alcoholic beverages during the 48 h preceding the study.Volunteers who do not maintain the conditions of fasting and food intake in the pre-established schedules.Volunteers who must start a scheduled medical or pharmacological treatment outside the this Protocol.Positive beta-HCG test in female volunteers.Female volunteers who are breastfeeding during the study period.Abnormal results outside the reference values for thyroid function (T3, T4, TSH, anti-TPO antibodies).Clinically significant abnormal laboratory test results.Having donated blood within the 3 months prior to the start of the study.Having participated in another research study in the last 6 months. ![]() Hypersensitivity to Levothyroxine sodium or to excipients (from formulations to test).History of seizure disorders, depressive disorders, cardiovascular diseases, hematological, metabolic, vesicular or other, that the Principal Investigator judges clinically significant.Ingestion of other drugs the 2 weeks prior to the start of the study.History of drug or alcohol abuse in the last two years.History of liver disease, kidney disease or conditions of psychiatric origin.Sex: both (male and female, homogenously distributed).Healthy volunteers according to antecedents, clinical evaluation, biochemical tests and other complimentary tests.There will be two treatment sequences (AB, BA) and a 42 day washout between the two treatment periods. 80 healthy adults will be randomized to receive a single dose (6 x 100 mcg tablets = 600 mcg) of the test formulation of levothyroxine and reference formulation of levothyroxine separately in each treatment period. This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study. It will then evaluate the impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test formulation) relative to the reference formulation from Merck (Reference formulation) Tecnoquimicas modified its Levothyroxine tablets formulation in order to comply with new pharmacopeial specifications. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Since small changes in levothyroxine administration (e.g. Levothyroxine is also endogenously produced in the body. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in lifelong therapy. Why Should I Register and Submit Results?. ![]()
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