Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

Healthy Clinical Trial

Official title:

Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03634371
• Other study ID #: Versión 3- BIO 096
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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