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OpenTrials
Completed

NCT Number: NCT05174000

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

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).

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Key information

Conditions

Healthy

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Euthyrox®

Drug

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

Other names: Levothyroxine sodium

Reference Euthyrox®

Drug

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

Other names: Levothyroxine sodium

Primary outcomes

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

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

  2. 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

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

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

  2. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2021
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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