Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
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.
Inclusion Criteria:

 -  Men and Women from 18 to 50 years old

 -  Diagnosed as healthy after a clinical examination

 -  BMI from 18 to 30 kg/m2

 -  Not smoking for at least 3 months

 -  To sign the informed consent

 -  Not having participated in a similar study for at least 4 months

 Exclusion Criteria:

 -  Renal, cardiac immunological, dermatological, endocrine, gastrointestinal,
 neurological or psychiatric condition

 -  Hematologic disorders, specially anemia and polycythemia

 -  Permanent or temporal pharmacological therapy, prescribed or not

 -  Smoking for the last 3 months

 -  Alcohol drinker more than once a week

 -  Drug abuse

 -  Drug hypersensitivity

 -  Angioedema or anaphylaxis history

 -  Pregnancy or breast-feeding

 -  HIV o Hepatitis B diagnosed

 -  Blood donor in the past 30 days