Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

NCT06547242 | Completed Phase 1

• 2 other identifiers: BCBE/21/BTX-BE/0012021-001454-62
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-72

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

  72 days

• Cmax

  Cmax of levothyroxine (baseline corrected) after each treatment

  72 days

Secondary Outcomes (7)

• AUC0-tlast

  72 days

• AUC0-∞

  72 days

• AUCexpol%

  72 days

• tmax

  72 days

• t1/2

  72 days

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Levothyroxin

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

ACTIVE COMPARATOR

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

Drug: Levothyroxin

Interventions

Levothyroxin DRUG

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

Also known as: BC-T4CYS 150 µg tablet (Berlin-Chemie AG)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (1)

Phase I Unit

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

Thyroxine; Tablets

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Warnke André, Dr.

  SocraTec R&D GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: October 22, 2021
• Primary Completion: March 22, 2022
• Study Completion: May 22, 2022
• Last Updated: August 9, 2024

Record last verified: 2022-01

Locations

DE (1)