Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Drug Levothyroxine 150 mcg; Drug: Drug Eutirox 150 mcg

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Chía, Colombia
    • Universidad de la Sabana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Formulation of Levothyroxine; Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2	Drug: Drug Levothyroxine 150 mcg; Administration of a 600 mcg levothyroxine dose
Active Comparator: Reference formulation of Levothyroxine; Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2	Drug: Drug Eutirox 150 mcg; Administration of a 600 mcg levothyroxine dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cmax for T3		From 0 to 48 hours
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
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

Collaborators and Investigators

• Sponsor: Tecnoquimicas

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Anticipated): October 6, 2018
• Study Completion (Anticipated): October 6, 2018

Study Registration Dates

• First Submitted: August 12, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Versión 3- BIO 096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No