Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDrug Levothyroxine 150 mcg
Administration of a 600 mcg levothyroxine dose
DRUGDrug Eutirox 150 mcg
Administration of a 600 mcg levothyroxine dose
Sponsors
Tecnoquimicas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (AUC) Area Under the Curve 0-48 for T4 | From 0 to 48 hours | -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours |
| Cmax for T4 | From 0 to 48 hours | -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-48 for T3 | From 0 to 48 hours | -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours |
| Cmax for T3 | From 0 to 48 hours | — |
| Tmax | From 0 to 48 hours | -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours |
| Kel | From 0 to 48 hours | -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours |
Countries
Colombia
Outcome results
None listed