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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03634371
Other study ID # Versión 3- BIO 096
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date August 10, 2018
Est. completion date October 6, 2018

Study information

Verified date August 2018
Source Tecnoquimicas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date October 6, 2018
Est. primary completion date October 6, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Drug Levothyroxine 150 mcg
Administration of a 600 mcg levothyroxine dose
Drug Eutirox 150 mcg
Administration of a 600 mcg levothyroxine dose

Locations

Country Name City State
Colombia Universidad de la Sabana Chía

Sponsors (1)

Lead Sponsor Collaborator
Tecnoquimicas

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary (AUC) Area Under the Curve 0-48 for T4 -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours From 0 to 48 hours
Primary Cmax for T4 -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours From 0 to 48 hours
Secondary AUC 0-48 for T3 -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours From 0 to 48 hours
Secondary Cmax for T3 From 0 to 48 hours
Secondary Tmax -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours From 0 to 48 hours
Secondary Kel -0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours From 0 to 48 hours
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