Clinical trial NCT03634371: Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
Official title: Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Tecnoquimicas
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: (AUC) Area Under the Curve 0-48 for T4
timeFrame: From 0 to 48 hours
measure: Cmax for T4
timeFrame: From 0 to 48 hours
Secondary outcomes:
measure: AUC 0-48 for T3
timeFrame: From 0 to 48 hours
measure: Cmax for T3
timeFrame: From 0 to 48 hours
measure: Tmax
timeFrame: From 0 to 48 hours
measure: Kel
timeFrame: From 0 to 48 hours
Other outcomes:
Locations:
city: Chía
country: Colombia
facility: Universidad de la Sabana
Study officials:
References: