Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg

NCT04573907 | Completed Phase 4

• 1 other identifier: PRO-BEQ-LEVO-007-V.01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• (AUC) Area Under the Curve 0-48 for T4

  -30 min., -15 min., 0 hour (h ) pre-dose; 30 min., 1 h, 1.30 h, 2 h, 2.30 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h , 48 hours

  [Time Frame: From 0 to 48 hours]

• (Cmax) Maximum concentration 0-48 for T4

  -30 min., -15 min., 0 hour ( h) pre-dose; 30 min., 1 h, 1.30 h, 2 h, 2.30 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h , 48 hours

  [Time Frame: From 0 to 48 hours]

Study Arms (2)

Test Formulation of Levothyroxine

EXPERIMENTAL

Levothyroxine sodium tablets 100 mcg Single dose of 600 mcg administered in dosing period 1 or 2

Drug: Drug Levothyroxine 100 mcg

Reference formulation of Levothyroxine

ACTIVE COMPARATOR

Eutirox 100 mcg Single dose of 600 mcg administered in dosing period 1 or 2

Drug: Drug Eutirox 100 mcg

Interventions

Drug Levothyroxine 100 mcg DRUG

Administration of a 600 mcg levothyroxine dose

Test Formulation of Levothyroxine

Drug Eutirox 100 mcg DRUG

Administration of a 600 mcg levothyroxine dose

Reference formulation of Levothyroxine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent
• Healthy volunteers according to antecedents, clinical evaluation, biochemical tests and other complimentary tests
• Sex: both (male and female, homogenously distributed)
• Age: 18 to 50 years old
• BMI: 18 to 30 kg/m2
• Non smokers from at least 3 months

You may not qualify if:

• History of liver disease, kidney disease or conditions of psychiatric origin.
• History of drug or alcohol abuse in the last two years.
• Ingestion of other drugs the 2 weeks prior to the start of the study.
• History of seizure disorders, depressive disorders, cardiovascular diseases, hematological, metabolic, vesicular or other, that the Principal Investigator judges clinically significant.
• Abnormal electrocardiogram (EKG).
• Hypersensitivity to Levothyroxine sodium or to excipients (from formulations to test).
• Positive HIV test; hepatitis B and C.
• Positive urine drug dose of abuse.
• Having participated in another research study in the last 6 months.
• Having donated blood within the 3 months prior to the start of the study.
• Clinically significant abnormal laboratory test results.
• Abnormal results outside the reference values for thyroid function (T3, T4, TSH, anti-TPO antibodies).
• Female volunteers who are breastfeeding during the study period.
• Positive beta-HCG test in female volunteers.
• Volunteers who must start a scheduled medical or pharmacological treatment outside the this Protocol.

Sponsors & Collaborators

• Tecnoquimicas: lead
• DominguezLab: collaborator

Study Sites (1)

DominguezLab

Paraná, Entre Ríos Province, Argentina

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: June 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)