Healthy Clinical Trial
Official title:
Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in
lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3).
Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine
administration (e.g. 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. Tecnoquimicas modified its
Levothyroxine tablets formulation in order to comply with new pharmacopeical specifications.
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)
This will be a single-center, open-label, two-period, two-treatment, two-sequence,
randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a
single dose (4 x 150 mcg tablets = 600 mcg) of the test formulation of levothyroxine and
reference formulation of levothyroxine separately in each treatment period. There will be two
treatment sequences (AB, BA) and a 42 day washout between the two treatment periods.
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