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Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg

NCT04573907 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-05

No results posted yet for this study

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

Interventions

DRUG

Drug Levothyroxine 100 mcg

Administration of a 600 mcg levothyroxine dose

DRUG

Drug Eutirox 100 mcg

Administration of a 600 mcg levothyroxine dose

Sponsors & Collaborators

  • DominguezLab

    collaborator UNKNOWN

  • Tecnoquimicas

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-10-01
Completion
2020-05-01

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573907 on ClinicalTrials.gov