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The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with each drug will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pyrotinib alone, then pyrotinib + Montmorillonite Power or Loperamide | Experimental | Sequential treatments of pyrotinib alone followed by pyrotinib + Montmorillonite Power or Loperamide, with a washout period in between. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyrotinib tablet | Drug | single oral dose of pyrotinib or co-administered with Montmorillonite Power or Loperamide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of pyrotinib | Maximum concentration (Cmax) of pyrotinib | Day 1 and Day 9 |
| AUC of pyrotinib | Area under the plasma concentration versus time curve of pyrotinib | Day 1 and Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (Tmax) of pyrotinib | Day 1 and Day 9 | |
| AEs and SAEs | Adverse events and serious adverse events | From the first drug administration to 7 days after the last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40433999 | Derived | Wang Y, Li D, Zhang T, Xu S, Zhang Y, Zhao K, Li S, Shen K, Li X, Xu P. Evaluation of the pharmacokinetic interactions of montmorillonite powder or loperamide on pyrotinib in healthy volunteers. Front Pharmacol. 2025 May 12;16:1563556. doi: 10.3389/fphar.2025.1563556. eCollection 2025. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Pyrotinib alone and then combined with Montmorillonite Power or Loperamide
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| Montmorillonite Power | Drug | 3 g or one pouch of montmorillonite power 2 hours after pyrotinib administration |
|
| Loperamide | Drug | 4 mg of loperamide with pyrotinib followed by 2mg every 2 hours for 2 times for a total of 8mg/day |
|
| PK parameters (CL/F) of pyrotinib | Day 1 and Day 9 |
| PK parameters (Vz/F) of pyrotinib | Day 1 and Day 9 |
| D017437 |
| Skin and Connective Tissue Diseases |