BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany56 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Test Euthyrox®DRUG

Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.

Reference Euthyrox®DRUG

Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Maximum Observed Serum Concentration, Adjusted for Baseline (Cmax[adj]) of Total Thyroxine (T4)

Time frame: Pre-dose up to 72 hours post-dose

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)

Time frame: Pre-dose up to 72 hours post-dose

Secondary Outcomes

Serum Concentrations of Total Thyroxine (T4) and Triiodothyronine (T3)

Time frame: Pre-dose up to 72 hours post-dose

Safety Profile as Assessed by Occurrence of Severity of Treatment-emergent Adverse Events (TEAEs), Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements

Time frame: Baseline up to 10 months

Data from ClinicalTrials.gov

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