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HealthyPhase 1NCT06547242

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

A Phase 1 study testing Levothyroxin in people with Healthy, run by Berlin-Chemie AG Menarini Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Levothyroxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteGermany
Study dates
22 Oct 2021to 22 May 2022
Phase
Phase 1
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ethnic origin: Caucasian
  • age: 18 years or older
  • body-mass index (BMI): 18.5 kg/m² and 30.0 kg/m²
  • good state of health
  • non-smoker or ex-smoker for at least 3 months
  • written informed consent, must be signed and dated before enrolment by the subject and the (sub-)investigator, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Who cannot join

  • Subjects cannot be included if they match any of the following exclusion criteria:
  • Safety concerns
  • existing cardiac, cardiovascular (e.g. angina pectoris, coronary heart disease) and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  • existing hepatic and/or renal diseases and/or endocrine diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
  • existing lipo-metabolic disorder or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
  • existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
Show all 40Show fewer
  • any disorder of thyroid glands reported in medical history resulting in an impairment of thyroid functions
  • existing diabetes mellitus
  • current treatment with anticoagulant drugs
  • history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  • existing epilepsy or current treatment with antiepileptic drugs
  • subjects with pulmonary diseases (bronchial asthma, bronchitis, COPD) or known respiratory depression
  • known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
  • history of significant drug allergy (especially hypersensitivity to levothyroxine-sodium)
  • subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  • systolic blood pressure < 90 or > 139 mmHg
  • diastolic blood pressure < 60 or > 89 mmHg
  • heart rate < 50 bpm or > 90 bpm
  • QTc interval > 450 ms for men and > 470 ms for women
  • laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
  • ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 % ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 µmol/l ULN).
  • positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
  • diagnosis of COVID-19 within the last 4 weeks and persisting disease symptoms (e.g. fever, cough) within 14 days prior to individual enrolment of the subject
  • direct contact with insufficient protection to persons in foreign risk regions for COVID-19 as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the subject
  • known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the subject Lack of suitability for the clinical trial
  • acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
  • history of or current drug or alcohol dependence
  • positive alcohol, cotinine or drug test at screening examination
  • regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day
  • subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
  • regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
  • blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual screening of the subject
  • administration of any investigational medicinal product during the last 2 months prior to individual screening of the subject
  • regular treatment with any systemically available medication (except hormonal contraceptives or common replacement therapy with estrogens). In case of treatment with hormonal contraceptives or common replacement therapy with estrogens, the treatment should have started at least 3 months prior to the first IMP administration and be regularly continued during the clinical trial.
  • current treatment with medication for malaria prophylaxis
  • subjects, who report a frequent occurrence of migraine attacks
  • radiography with contrast medium within the last 6 weeks prior to the first administration
  • For female subjects with childbearing potential only:
  • 36. positive pregnancy test at screening examination 37. pregnant or lactating women 38. female subjects who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1) Administrative reasons 39. employee or family member of the Sponsor or the involved contract research organisation (CRO) 40. vulnerable subject defined as a soldier, a subject kept in detention, a protected adult under guardianship/trusteeship or committed to an institution by governmental or juridical order 41. subjects suspected or known not to follow instructions 42. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial 43. no suitable candidate in the opinion of the investigator
  • -

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Phase I Unit

    Erfurt, Thuringia, 99084

Other trials in Germany

About this study

Official title: Bioequivalence Trial of BC-T4CYS 150 µg Tablets Versus Letrox® 150 µg in Healthy Subjects

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Read the detailed description

Single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, single dose cross-over trial with administrations under fasting conditions separated by a washout period of at least 45 treatment-free days

Conditions
Healthy
Being tested
Levothyroxin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevothyroxinDrug

    Also called BC-T4CYS 150 µg tablet (Berlin-Chemie AG)

    Single-dose administration of 600 mcg of Levothyroxin for the assessment of bioequivalence

  • LevothyroxinDrug

    Also called Letrox® 150 µg tablet (Berlin-Chemie AG),

    Single-dose administration of 600 mcg of Levothyroxin for the assessment of bioequivalence

Study groups in NCT06547242
Study groupRoleWhat they receive
BC-T4CYS 150 µg tablet (Berlin-Chemie AG)ExperimentalBC-T4CYS 150 µg tablet (Berlin-Chemie AG), oral single dose administration of 4 tablets (600 µg levothyroxine-sodium)
Receives: Drug: Levothyroxin
Letrox® 150 µg tablet (Berlin-Chemie AG),Active comparatorLetrox® 150 µg tablet (Berlin-Chemie AG), oral single dose administration of 4 tablets (600 µg levothyroxine-sodium)
Receives: Drug: Levothyroxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-72

    AUC0-72 of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  2. Cmax

    Cmax of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

Secondary outcomes (7)

  1. AUC0-tlast

    AUC0-tlast of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  2. AUC0-∞

    AUC0-∞ of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  3. AUCexpol%

    AUCexpol% of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  4. tmax

    tmax of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  5. t1/2

    t1/2 of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  6. λz

    λz of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

  7. tlag

    tlag of levothyroxine (baseline corrected) after each treatment

    Measured: 72 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start22 Oct 2021
  3. Primary completion22 Mar 2022
  4. Study completion22 May 2022

Resources

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Single centre, open-label, randomised (order of treatments), balanced, 2-period, 2-sequence, single dose cross-over trial with administrations under fasting conditions separated by a washout period of at least 45 treatment-free days
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547242
Sponsor's protocol ID
BCBE/21/BTX-BE/001
Other IDs
2021-001454-62
Status last verified
Jan 2022
First submitted
7 Aug 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Levothyroxin in people with Healthy, run by Berlin-Chemie AG Menarini Group at 1 site in Germany.

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 40 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 9 Aug 2024. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AUC0-72 (time frame: 72 days). 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?

On the ClinicalTrials.gov record for NCT06547242.

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 9 Aug 2024.

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