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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05174000
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
11.8
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Test Euthyrox®
  • Drug: Reference Euthyrox®
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Jan 3, 2023
Anticipated Study Completion Date :
Jan 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence 1:Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®

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®
Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.
Other Names:
  • Levothyroxine sodium

    • Drug: Reference Euthyrox®
    Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.
    Other Names:
  • Levothyroxine sodium

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

    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®
    Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.
    Other Names:
  • Levothyroxine sodium

    • Drug: Reference Euthyrox®
    Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.
    Other Names:
  • Levothyroxine sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Serum Concentration, Adjusted for Baseline (Cmax[adj]) of Total Thyroxine (T4) [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) [Pre-dose up to 72 hours post-dose]

    Secondary Outcome Measures

    1. Serum Concentrations of Total Thyroxine (T4) and Triiodothyronine (T3) [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 [Baseline up to 10 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital, Capital Medical University Beijing China

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT05174000
    Other Study ID Numbers:
    • MS200125_0006
    First Posted:
    Dec 30, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Euthyrox®
    Bioequivalence
    Thyroid-Stimulating Hormone
    Thyroxine

    Study Results

    No Results Posted as of Aug 2, 2022