Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

NCT ID: NCT06547242

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2022-05-22

Brief Summary

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

BC-T4CYS 150 µg tablet (Berlin-Chemie AG), oral single dose administration of 4 tablets (600 µg levothyroxine-sodium)

Group Type: EXPERIMENTAL

Levothyroxin

Intervention Type: DRUG

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

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

Letrox® 150 µg tablet (Berlin-Chemie AG), oral single dose administration of 4 tablets (600 µg levothyroxine-sodium)

Group Type: ACTIVE_COMPARATOR

Levothyroxin

Intervention Type: DRUG

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

Interventions

Levothyroxin

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

Intervention Type: DRUG

Levothyroxin

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

Intervention Type: DRUG

Other Intervention Names

BC-T4CYS 150 µg tablet (Berlin-Chemie AG); Letrox® 150 µg tablet (Berlin-Chemie AG),

Eligibility Criteria

Inclusion Criteria

1. ethnic origin: Caucasian

2. age: 18 years or older

3. body-mass index (BMI): 18.5 kg/m² and 30.0 kg/m²

4. good state of health

5. non-smoker or ex-smoker for at least 3 months

6. 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

Exclusion Criteria

Safety concerns

1. 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

2. 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

3. existing lipo-metabolic disorder or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient

4. existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient

5. any disorder of thyroid glands reported in medical history resulting in an impairment of thyroid functions

6. existing diabetes mellitus

7. current treatment with anticoagulant drugs

8. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders

9. existing epilepsy or current treatment with antiepileptic drugs

10. subjects with pulmonary diseases (bronchial asthma, bronchitis, COPD) or known respiratory depression

11. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations

12. history of significant drug allergy (especially hypersensitivity to levothyroxine-sodium)

13. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator

14. systolic blood pressure < 90 or > 139 mmHg

15. diastolic blood pressure < 60 or > 89 mmHg

16. heart rate < 50 bpm or > 90 bpm

17. QTc interval > 450 ms for men and > 470 ms for women

18. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator

19. 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).

20. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test

21. 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

22. 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

23. 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

24. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP

25. history of or current drug or alcohol dependence

26. positive alcohol, cotinine or drug test at screening examination

27. regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day

28. subjects who are on a diet which could affect the pharmacokinetics of the active ingredient

29. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day

30. blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual screening of the subject

31. administration of any investigational medicinal product during the last 2 months prior to individual screening of the subject

32. 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.

33. current treatment with medication for malaria prophylaxis

34. subjects, who report a frequent occurrence of migraine attacks

35. 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

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Berlin-Chemie AG Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warnke André, Dr.

Role: STUDY_DIRECTOR

SocraTec R&D GmbH

Locations

Phase I Unit

Erfurt, Thuringia, Germany

Countries

Germany

Other Identifiers

2021-001454-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BCBE/21/BTX-BE/001

Identifier Type: -

Identifier Source: org_study_id