CompletedPhase 1

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Germany132 participantsStarted 2021-10-22

Plain-language summary

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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

AUC0-72

Timeframe: 72 days

Cmax

Timeframe: 72 days

NCT IDNCT06547242

SponsorBerlin-Chemie AG Menarini Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-22

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. 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