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

NCT ID: NCT05174000

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-10-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Test Euthyrox®

Intervention Type: DRUG

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

Reference Euthyrox®

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Test Euthyrox®

Intervention Type: DRUG

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

Reference Euthyrox®

Intervention Type: DRUG

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

Interventions

Test Euthyrox®

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

Intervention Type: DRUG

Reference Euthyrox®

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

Intervention Type: DRUG

Other Intervention Names

Levothyroxine sodium; Levothyroxine sodium

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

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

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200125_0006

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

MS200125_0006

Identifier Type: -

Identifier Source: org_study_id