Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
1 other identifier
interventional
80
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Aug 2018
Shorter than P25 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2018
CompletedFirst Submitted
Initial submission to the registry
August 12, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2018
CompletedAugust 16, 2018
August 1, 2018
2 months
August 12, 2018
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
(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 Outcomes (4)
AUC 0-48 for T3
From 0 to 48 hours
Cmax for T3
From 0 to 48 hours
Tmax
From 0 to 48 hours
Kel
From 0 to 48 hours
Study Arms (2)
Test Formulation of Levothyroxine
EXPERIMENTALLevothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
Reference formulation of Levothyroxine
ACTIVE COMPARATOREutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
Interventions
Administration of a 600 mcg levothyroxine dose
Administration of a 600 mcg levothyroxine dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tecnoquimicaslead
Study Sites (1)
Universidad de la Sabana
Chía, Colombia
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Biopharmaceutical Studies Director
Study Record Dates
First Submitted
August 12, 2018
First Posted
August 16, 2018
Study Start
August 10, 2018
Primary Completion
October 6, 2018
Study Completion
October 6, 2018
Last Updated
August 16, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share