HealthyPhase 4NCT04573907
Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
A Phase 4 study testing Drug Levothyroxine 100 mcg and Drug Eutirox 100 mcg in people with Healthy, run by Tecnoquimicas at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug Levothyroxine 100 mcg and Drug Eutirox 100 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2019to 1 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
- Volunteers who do not maintain the conditions of fasting and food intake in the pre-established schedules.
- Volunteers who do not avoid the intake of coffee, tea, grapefruit, cola and / or alcoholic beverages during the 48 h preceding the study.
- Volunteers on a special diet in the last 28 days (eg vegetarian diet, etc.).
- Volunteers with clinically significant allergies to food, medication, etc.
- Non-cooperative volunteers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Bioavailability Study of Levothyroxine Sodium Tablets 100 mcg in Healthy Volunteers
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.
Read the 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 pharmacopeial 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 (6 x 100 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
- Being tested
- Drug Levothyroxine 100 mcg, Drug Eutirox 100 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Levothyroxine 100 mcgDrug
Administration of a 600 mcg levothyroxine dose
Drug Eutirox 100 mcgDrug
Administration of a 600 mcg levothyroxine dose
| Study group | Role | What they receive |
|---|---|---|
| Test Formulation of Levothyroxine | Experimental | Levothyroxine sodium tablets 100 mcg Single dose of 600 mcg administered in dosing period 1 or 2 Receives: 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 Receives: Drug: Drug Eutirox 100 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: [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
Measured: [Time Frame: From 0 to 48 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jun 2019
- Primary completion1 Oct 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnoquimicas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DominguezLab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573907
- Sponsor's protocol ID
- PRO-BEQ-LEVO-007-V.01
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Study of Levothyroxine Sodium Tablets 100 mcg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04573907
- Acronym / sponsor ID
- PRO-BEQ-LEVO-007-V.01
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TecnoquimicasIndustry (pharma, biotech, devices)
- Collaborators
- DominguezLab
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pharmacopeial 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 (6 x 100 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Formulation of Levothyroxine | Experimental | Drug: Drug Levothyroxine 100 mcgLevothyroxine sodium tablets 100 mcg Single dose of 600 mcg administered in dosing period 1 or 2 |
| Reference formulation of Levothyroxine | Active comparator | Drug: Drug Eutirox 100 mcgEutirox 100 mcg Single dose of 600 mcg administered in dosing period 1 or 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Levothyroxine 100 mcgAdministration of a 600 mcg levothyroxine dose | Drug | Test Formulation of Levothyroxine |
| Drug Eutirox 100 mcgAdministration of a 600 mcg levothyroxine dose | Drug | Reference formulation of Levothyroxine |
Primary outcome
(AUC) Area Under the Curve 0-48 for T4
Time frame: [Time Frame: From 0 to 48 hours]
-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
(Cmax) Maximum concentration 0-48 for T4
Time frame: [Time Frame: From 0 to 48 hours]
-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug Levothyroxine 100 mcg and Drug Eutirox 100 mcg in people with Healthy, run by Tecnoquimicas at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(AUC) Area Under the Curve 0-48 for T4 (time frame: [Time Frame: From 0 to 48 hours]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.