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The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Eutirox®, then Test Eutirox® | Experimental | Participants received single oral dose of Reference Eutirox® 600 microgram (mcg) (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
|
| Test Eutirox®, then Reference Eutirox® | Experimental | Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Eutirox® | Drug | Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration in Pre Dose Corrected Data (Cmax[aj]) of Levothyroxine (T4) | Cmax was obtained from the concentration time curve. Cmax[aj] was the maximum serum concentration in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration. | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Area Under Serum Concentration-Time Curve From Time Zero to The Last Sampling Time in Pre Dose Corrected Data (AUC0-t [aj]) of Levothyroxine (T4) | AUC0-t was defined as area under the curve of the serum concentration as a function of time, from time 0 until the last sampling time by means of the trapezoidal rule. AUC0-t [aj] was the area under the serum concentration-time curve from time zero to the last sampling time in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration. | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4) | Tmax was obtained directly from serum concentration-time curve. | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Elimination Half-Life (t1/2) of Levothyroxine (T4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cecype, Fray Bernardino de Sahagún | Morelia - Michoacan | 58249 | Mexico |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Eutirox®, Then Test Eutirox® | Participants received single oral dose of Reference Eutirox® 600 microgram (mcg) (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
| FG001 | Test Eutirox®, Then Reference Eutirox® | Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 1 followed by single oral dosing of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in Treatment Period 2. A wash-out period of 35 days was maintained between the Treatment Periods 1 and 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Treatment Period 2 |
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Safety analysis set included all randomized participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received a single oral dose of Reference Eutirox® 600 mcg (200*3 mcg) or a single oral dose of test Eutirox® 600 mcg (200*3 mcg) in either Treatment Period 1 or 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Serum Concentration in Pre Dose Corrected Data (Cmax[aj]) of Levothyroxine (T4) | Cmax was obtained from the concentration time curve. Cmax[aj] was the maximum serum concentration in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration. | Pharmacokinetic (PK) analysis set included all randomized participants who received study medication in both treatment periods. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
|
Baseline up to Day 51
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Eutirox® | Participants received single oral dose of Reference Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2018 | Jan 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2020 | Jan 11, 2021 | SAP_001.pdf |
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| Test Eutirox® | Drug | Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2. |
|
t1/2 was the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by elimination constant. |
| Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Area Under The Curve of the Serum Concentration as a Function of Time, From Time Zero to The Last Sampling Time (AUC0-t) of Levothyroxine (T4) | Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Maximum Serum Concentration (Cmax) of Levothyroxine (T4) | Cmax was obtained directly from the concentration versus time curve. | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Physical examination included assessments of the general appearance, skin and mucosa, superficial lymph nodes, head and neck, chest, abdomen, musculoskeletal, and neurological systems. Number of participants with clinically significant abnormalities in physical examination findings were reported. Investigator decided clinical significance. | Baseline up to Day 37 |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign assessment included blood pressure, pulse rate, body temperature and respiration. Number of participants with clinically significant abnormalities in vital signs were reported. Investigator decided clinical significance. | Baseline up to Day 37 |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | The laboratory measurements included hematology, blood chemistry and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters were reported. Investigator decided clinical significance. | Baseline up to Day 37 |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | The ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant abnormalities in ECG were reported. Investigator decided clinical significance. | Baseline up to Day 37 |
| Number of Participants With Adverse Events (AEs) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. Number of participants with adverse events were reported. | Baseline up to Day 51 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | Test Eutirox® | Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions. |
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| Primary | Area Under Serum Concentration-Time Curve From Time Zero to The Last Sampling Time in Pre Dose Corrected Data (AUC0-t [aj]) of Levothyroxine (T4) | AUC0-t was defined as area under the curve of the serum concentration as a function of time, from time 0 until the last sampling time by means of the trapezoidal rule. AUC0-t [aj] was the area under the serum concentration-time curve from time zero to the last sampling time in pre dose corrected data where pre dose corrected data was obtained by subtracting pre dose level of Levothyroxine (T4) from level of Levothyroxine (T4) after administration. | PK analysis set included all randomized participants who received study medication in both treatment periods. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
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| Secondary | Time to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4) | Tmax was obtained directly from serum concentration-time curve. | PK analysis set included all randomized participants who received study medication in both treatment periods. | Posted | Mean | Standard Deviation | hour | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
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| Secondary | Elimination Half-Life (t1/2) of Levothyroxine (T4) | t1/2 was the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by elimination constant. | PK analysis set included all randomized participants who received study medication in both treatment periods. | Posted | Mean | Standard Deviation | hour | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
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| Secondary | Area Under The Curve of the Serum Concentration as a Function of Time, From Time Zero to The Last Sampling Time (AUC0-t) of Levothyroxine (T4) | Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). | PK analysis set included all randomized participants who received study medication in both treatment periods. | Posted | Mean | Standard Deviation | ng*hour/mL | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
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| Secondary | Maximum Serum Concentration (Cmax) of Levothyroxine (T4) | Cmax was obtained directly from the concentration versus time curve. | PK analysis set included all randomized participants who received study medication in both treatment periods. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.5, 6.0, 6.5, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination | Physical examination included assessments of the general appearance, skin and mucosa, superficial lymph nodes, head and neck, chest, abdomen, musculoskeletal, and neurological systems. Number of participants with clinically significant abnormalities in physical examination findings were reported. Investigator decided clinical significance. | Safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 37 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign assessment included blood pressure, pulse rate, body temperature and respiration. Number of participants with clinically significant abnormalities in vital signs were reported. Investigator decided clinical significance. | Safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 37 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | The laboratory measurements included hematology, blood chemistry and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters were reported. Investigator decided clinical significance. | Safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 37 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | The ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant abnormalities in ECG were reported. Investigator decided clinical significance. | Safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 37 |
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| Secondary | Number of Participants With Adverse Events (AEs) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. Number of participants with adverse events were reported. | Safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 51 |
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| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Test Eutirox® | Participants received single oral dose of Test Eutirox® 600 mcg (3 tablets of 200 mcg) in either Treatment Period 1 or 2 under fasting conditions. | 0 | 44 | 0 | 44 | 4 | 44 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Elevated Alanine Aminotransferase | Investigations | Non-systematic Assessment |
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| Elevated Aspartate Aminotransferase | Investigations | Non-systematic Assessment |
|
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