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

NCT05174000 | Completed Phase 1

• 1 other identifier: MS200125_0006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Euthyrox®; Bioequivalence; Thyroid-Stimulating Hormone; Thyroxine

Outcome Measures

Primary Outcomes (2)

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

  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)

  Pre-dose up to 72 hours post-dose

Secondary Outcomes (2)

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

  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

  Baseline up to 10 months

Study Arms (2)

Sequence 1:Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®

EXPERIMENTAL

Participants will receive single oral dose of Test Euthyrox® on in treatment period 1, followed by single oral dose of Reference Euthyrox® in treatment period 2, followed by single oral dose of Test Euthyrox® in treatment period 3, followed by single oral dose of Reference Euthyrox in treatment period 4. Participants will remain resident until Day 4 for each treatment period and there will be a washout period of 53 days between each treatment period.

Drug: Test Euthyrox®; Drug: Reference Euthyrox®

Sequence 2:Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®

EXPERIMENTAL

Participants will receive single oral dose of Reference Euthyrox® in treatment period 1, followed by single oral dose of Test Euthyrox® in treatment period 2, followed by single oral dose of Reference Euthyrox® in treatment period 3, followed by single oral dose of Test Euthyrox® in treatment period 4. Participants will remain resident until Day 4 for each treatment period and there will be a washout period of 53 days between each treatment period.

Drug: Test Euthyrox®; Drug: Reference Euthyrox®

Interventions

Test Euthyrox® DRUG

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

Also known as: Levothyroxine sodium

Sequence 1:Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®; Sequence 2:Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®

Reference Euthyrox® DRUG

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

Also known as: Levothyroxine sodium

Sequence 1:Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®; Sequence 2:Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Thyroxine

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

Study Officials

• Medical Responsible

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

  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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 30, 2021
• Study Start: January 10, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)