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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Euthyrox® | Drug | Participants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Reference Euthyrox® | Drug | Participants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4. |
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| Baseline up to 10 months |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |