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CompletedNCT03979274Updated Feb 5, 2021Results posted

A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers

A Phase 1 interventional study of Reference Eutirox® and Test Eutirox® in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-05.

Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.

02

Conditions studied

  • Healthy

Keywords

  • Eutirox
  • Levothyroxine
03

In context

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants who have provided their written consent prior to any study-related activity
  • Ethnic origin: Mexicans
  • Body mass index from 18 to 27 kilogram per meter square (kg/m\^2)
  • Normal vital signs (includes heart rate between 50 and 100 beats per minute, respiratory rate between 12 and 20 per minute, systolic blood pressure between 80 and 129 milimeter of mercury (mmHg) , diastolic blood pressure between 50 and 80 mmHg and temperature between 36.0 degree celsius and 37.0 degree celsius. The measurement will be made according to the instructive BE-IT-005 Medición de signos vitales)
  • Normal electrocardiogram [ECG]. No abnormalities are allowed, even though they are not relevant (PR, QRS, QT, QTcF should be within normal range; no conduction abnormalities are allowed, etcetera (etc)
  • All values in blood and urine tests should be within the normal range or showing no clinically relevant deviation as judged by the Investigator
  • Participants with thyroid panel results within normal range (T3 and T4 total and free, as well as thyroid-stimulating hormone (TSH) should be within the normal range)
  • Non-smoker at least in the last 3 months
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

Exclusion Criteria:

  • Participation in the clinical study within 90 days prior to the first dose of the study drug
  • History of hypersensitivity to the study drug or its excipients
  • History or current asthma or any severe allergy (which requires hospitalization or prolonged therapy), allergy or intolerance to any food that, in the opinion of the investigator, poses a safety risk (allergy to iodine)
  • History of cardiovascular, renal, liver, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia) conditions, mental disorder or organic abnormalities that may affect the pharmacokinetic study of the study drug
  • Any medical or surgical condition, including findings in the medical history or clinical assessment prior to the study, that in the opinion of the investigator poses a risk or contraindication for the participants participation in the study and may affect the study objectives, conduct or analysis
  • History or presence of alcohol abuse (average daily intake not higher than 3 units or weekly intake not higher than 21 units; 1 unit is equivalent to 340 mililiter (mL) of beer, 115 mL of wine or 43 mL of prepared drinks), psychoactive substances or chronic use of drugs
  • Participants who have been exposed to agents knows by inducing or inhibiting the liver enzymatic systems or who have taken potentially toxic drugs within the last 30 days to the study start-up
  • Participants who take drugs affecting the metabolism of the thyroid hormone, such as: oral contraceptives, hormonal implants, parenteral hormones, steroids, anabolic drugs, androgens, etc., or any drug affecting the levothyroxine's bioavailability such as the proton pump inhibitors or multivitamins, nutritional supplements or herbal products that may affect the study, except for the occasional use of paracetamol
  • Participants who have been hospitalized for any reason within the 60 days prior to the study start-up or who have been severely ill within the last 30 days prior to the study start-up
  • Participants who have donated or lost 450 mL of blood within the last 60 days prior to the study start-up
  • Participants non- smokers, who have smoked tobacco, cigarettes or consumed coffee, snuff or drinks containing xanthines such as caffeine, (tea, cocoa, chocolate, matte, cola, etc.) theobromine, theophylline, among others, affecting the pharmacokinetics of the drug in assessment, drinking alcohol, or charcoal-grilled foods consumed within twenty-four hours prior to administration the dose of medication
  • Screening biosafety positive tests for the human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis Venereal Disease Research Laboratory (VDRL)
  • Positive result in the abuse drugs screening tests, such as: amphetamines, benzodiazepines, cocaine, methamphetamines, morphine and tetrahydrocannabinoids
  • Presence of alcohol in breath test
  • Women pregnancy positive tests (qualitative and quantitative) at the screening and inclusion in each period
  • Other protocol defined exclusion criteria could apply
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Reference Eutirox® · Drug: Test Eutirox®

  • Experimental
    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.

    Drug: Reference Eutirox® · Drug: Test Eutirox®

Interventions

  • DrugReference Eutirox®

    Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2.

  • DrugTest Eutirox®

    Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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

Secondary outcomes

  1. Time to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4)

    Tmax was obtained directly from serum concentration-time curve.

    Time frame: 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

  2. 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.

    Time frame: 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

  3. 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).

    Time frame: 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

  4. Maximum Serum Concentration (Cmax) of Levothyroxine (T4)

    Cmax was obtained directly from the concentration versus time curve.

    Time frame: 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

  5. 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.

    Time frame: Baseline up to Day 37

  6. 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.

    Time frame: Baseline up to Day 37

  7. 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.

    Time frame: Baseline up to Day 37

  8. 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.

    Time frame: Baseline up to Day 37

  9. 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.

    Time frame: Baseline up to Day 51

07

Results

Posted Feb 5, 2021

Participant flow

Treatment Period 1
Participant flow — Treatment Period 1
MilestoneReference Eutirox®, Then Test Eutirox®Test Eutirox®, Then Reference Eutirox®
Started2222
Completed2222
Not completed00
Treatment Period 2
Participant flow — Treatment Period 2
MilestoneReference Eutirox®, Then Test Eutirox®Test Eutirox®, Then Reference Eutirox®
Started2222
Completed2221
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryMaximum 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.

Time frame:
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
Reported as:
Mean · nanogram per milliliter (ng/mL)
Maximum Serum Concentration in Pre Dose Corrected Data (Cmax[aj]) of Levothyroxine (T4)
nanogram per milliliter (ng/mL)Refernece Eutirox®Test Eutirox®
Maximum Serum Concentration in Pre Dose Corrected Data (Cmax[aj]) of Levothyroxine (T4)67.24 ± 15.7766.44 ± 15.77
Statistical analysis
  • Refernece Eutirox® vs Test Eutirox® · Geometric mean ratio: 98.53 · 90% CI 94.55 to 102.68
PrimaryArea 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.

Time frame:
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
Reported as:
Mean · nanogram*hour per milliliter (ng*hr/mL)
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)
nanogram*hour per milliliter (ng*hr/mL)Refernece Eutirox®Test Eutirox®
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)1738.65 ± 438.931693.89 ± 389.50
Statistical analysis
  • Refernece Eutirox® vs Test Eutirox® · Geometric mean ratio: 97.59 · 90% CI 91.34 to 104.26
SecondaryTime to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4)

Tmax was obtained directly from serum concentration-time curve.

Time frame:
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
Reported as:
Mean · hour
Time to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4)
hourRefernece Eutirox®Test Eutirox®
Time to Reach Maximum Serum Concentration (Tmax) of Levothyroxine (T4)3.52 ± 1.193.50 ± 1.14
SecondaryElimination 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.

Time frame:
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
Reported as:
Mean · hour
Elimination Half-Life (t1/2) of Levothyroxine (T4)
hourRefernece Eutirox®Test Eutirox®
Elimination Half-Life (t1/2) of Levothyroxine (T4)186.40 ± 96.26189.10 ± 102.07
SecondaryArea 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).

Time frame:
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
Reported as:
Mean · ng*hour/mL
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)
ng*hour/mLRefernece Eutirox®Test Eutirox®
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)5229.98 ± 562.735218.87 ± 587.42
Statistical analysis
  • Refernece Eutirox® vs Test Eutirox® · Geometric mean ratio: 99.73 · 90% CI 98.45 to 101.03
SecondaryMaximum Serum Concentration (Cmax) of Levothyroxine (T4)

Cmax was obtained directly from the concentration versus time curve.

Time frame:
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
Reported as:
Mean · ng/mL
Maximum Serum Concentration (Cmax) of Levothyroxine (T4)
ng/mLRefernece Eutirox®Test Eutirox®
Maximum Serum Concentration (Cmax) of Levothyroxine (T4)139.80 ± 16.16139.17 ± 19.24
Statistical analysis
  • Refernece Eutirox® vs Test Eutirox® · Geometric mean ratio: 99.26 · 90% CI 97.70 to 100.85
SecondaryNumber 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.

Time frame:
Baseline up to Day 37
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examination
ParticipantsRefernece Eutirox®Test Eutirox®
Number of Participants With Clinically Significant Abnormalities in Physical Examination00
SecondaryNumber 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.

Time frame:
Baseline up to Day 37
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Vital Signs
ParticipantsRefernece Eutirox®Test Eutirox®
Number of Participants With Clinically Significant Abnormalities in Vital Signs00
SecondaryNumber 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.

Time frame:
Baseline up to Day 37
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
ParticipantsRefernece Eutirox®Test Eutirox®
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters02
SecondaryNumber 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.

Time frame:
Baseline up to Day 37
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
ParticipantsRefernece Eutirox®Test Eutirox®
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)00
SecondaryNumber 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.

Time frame:
Baseline up to Day 51
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsRefernece Eutirox®Test Eutirox®
Number of Participants With Adverse Events (AEs)04

Adverse events

Collected over Baseline up to Day 51. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Reference Eutirox®0/44 (0%)0/44 (0%)0/44 (0%)
Test Eutirox®0/44 (0%)0/44 (0%)4/44 (9.1%)
Most frequent other events
Most frequent other events
EventReference Eutirox®Test Eutirox®
Elevated Alanine AminotransferaseInvestigations0/442/44
Elevated Aspartate AminotransferaseInvestigations0/442/44
DizzinessNervous system disorders0/441/44
Nasal congestionRespiratory, thoracic and mediastinal disorders0/441/44

Baseline characteristics

Safety analysis set included all randomized participants who received at least one dose of study medication.

Age, Continuous
Age, Continuous(years)All Participants
Mean25.93 ± 5.93
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female8
Male36
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)All Participants
08

Study locations

1 site
  • Cecype, Fray Bernardino de Sahagún
    Morelia - Michoacan, 58249, Mexico
09

References and documents

Study documents

  • Study protocol · Oct 18, 2018
  • Statistical analysis plan · Mar 10, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03979274
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Jun 7, 2019
Start date
Dec 6, 2019
Primary completion
Jan 13, 2020
Completion
Jan 25, 2020
Results posted
Feb 5, 2021
Last update
Feb 5, 2021

Study contacts

Medical Responsible
study director · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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