Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

NCT ID: NCT03634371

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2018-10-06

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Formulation of Levothyroxine

Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2

Group Type: EXPERIMENTAL

Drug Levothyroxine 150 mcg

Intervention Type: DRUG

Administration of a 600 mcg levothyroxine dose

Reference formulation of Levothyroxine

Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2

Group Type: ACTIVE_COMPARATOR

Drug Eutirox 150 mcg

Intervention Type: DRUG

Administration of a 600 mcg levothyroxine dose

Interventions

Drug Levothyroxine 150 mcg

Administration of a 600 mcg levothyroxine dose

Intervention Type: DRUG

Drug Eutirox 150 mcg

Administration of a 600 mcg levothyroxine dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tecnoquimicas

INDUSTRY

Sponsor Role: lead

Responsible Party

Mauricio Vargas

Biopharmaceutical Studies Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de la Sabana

Chía, , Colombia

Countries

Colombia

Other Identifiers

Versión 3- BIO 096

Identifier Type: -

Identifier Source: org_study_id