A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10
 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the
 result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from
 low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone
 production by the thyroid gland. Every tissue in the body is a thyroid hormone target and
 hypothyroid symptoms can be debilitating.

 BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt
 utilized as the active ingredient in currently marketed products.

 The current "gold standard" for treatment of hypothyroidism are products containing
 Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3
 by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally
 not euthyroid as measured by clinical presentation, a condition hypothesized to result from
 low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of
 conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the
 patient.

 BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented
 formulation and granulation procedure that solves multiple clinical and stability problems
 associated with T3-based products. Thus, BCT303 is designed to have:

 1. Increased shelf stability to ensure the maintenance of claimed dosage.

 2. A sustained-release profile to minimize side effects associated with spikes in serum T3
 levels.

 3. Uniformity of dose between production batches and between tablets.
Inclusion Criteria:

 -  Healthy adults

 -  Must be able to swallow tablets

 Exclusion Criteria:

 -  Hypothyroid Disease

 -  Pregnant Females