Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
- Registration Number
- NCT03634371
- Lead Sponsor
- Tecnoquimicas
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reference formulation of Levothyroxine Drug Eutirox 150 mcg Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2 Test Formulation of Levothyroxine Drug Levothyroxine 150 mcg Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
- Primary Outcome Measures
Name Time Method (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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Universidad de la Sabana
🇨🇴Chía, Colombia