Clinical trial NCT05174000: BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
Official title: An Open-label, Single-dose, Randomized, 4-period, 2-sequence, Fully Replicated Crossover, Single-center Phase I Study to Assess Bioequivalence in Healthy Participants Between Euthyrox® Tablets Manufactured at Merck Nantong Versus Euthyrox® Tablets Manufactured at Merck Darmstadt Administered Orally as 12 Tablets of 50 μg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Euthyrox®
Bioequivalence
Thyroid-Stimulating Hormone
Thyroxine
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2021-12-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck Darmstadt (Reference Euthyrox).


Eligibility criteria: Inclusion Criteria:

* Participants have a body weight within 45 to 75 kilogram (kg) for females and 55 to 85 kg for males and Body mass index (BMI) within the range 19.0 to 26.0 kilograms per meter square (kg/m\^2)
* Non-smoker for at least 3 months
* Contraceptive use by males or females will be consistent with any local regulations on contraception methods for those participating in clinical studies
* Capable of giving signed informed consent
* Total and free Thyroxine (T4), total and free Triiodothyronine (T3) and Thyroid-stimulating Hormone (TSH) must be within normal ranges at Screening
* Ability to understand the purposes and risks of the study
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with history or presence of tumors of the pituitary gland or hypothalamus, thyroid or adrenal gland dysfunction or cardiac disease
* Participants with a concurrent medical condition known to interfere with the absorption or metabolism of thyroid hormones
* History or presence of relevant liver diseases or hepatic dysfunction. Participants with gall bladder removal
* Participants taking medications known to affect thyroid hormone metabolism, for example, oral contraceptives, hormonal implants, parenteral hormones, anabolic steroids, androgens, etcetera
* Use of any investigational device within 60 days prior to first dose administration
* Pregnant or breastfeeding a child
* Participant has smoked within the 3 months prior to Screening
* High fiber consumption within 24 hours before dosing in each period
* Participants with positive results from serology examination for Syphilis, Hepatitis B surface antigen, Hepatitis C Virus or Human Immunodeficiency Virus
* Participants with any clinically relevant abnormality in the safety laboratory parameters
* Participants with positive test for drugs of abuse (including alcohol) at Screening and on Day -1 of each period (urine)
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Maximum Observed Serum Concentration, Adjusted for Baseline (Cmax[adj]) of Total Thyroxine (T4)
timeFrame: Pre-dose up to 72 hours post-dose
measure: Baseline-Corrected Area Under the Serum Concentration-Time Curve (AUC) from Time Zero to 72 hours Post-dose (AUC0-72,adj) of Total Thyroxine (T4)
timeFrame: Pre-dose up to 72 hours post-dose
Secondary outcomes:
measure: Serum Concentrations of Total Thyroxine (T4) and Triiodothyronine (T3)
timeFrame: Pre-dose up to 72 hours post-dose
measure: Safety Profile as Assessed by Occurrence of Severity of Treatment-emergent Adverse Events (TEAEs), Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
timeFrame: Baseline up to 10 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: