A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.