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The primary objective of the study was to assess the effect of repeated oral doses of Loperamide on the pharmacokinetic profile of a single dose of Pyrotinib Maleate.
The secondary objective of the study was to assess the safety of Pyrotinib Maleate given alone versus Fluzoparib coadministered with Loperamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treament | Experimental | Subjects receiving a single oral dose of pyrotinib maleate and wash-out for 6 days, then receiving Loperamide 4 mg bid from day 7 to day 13, with a single oral dose of pyrotinib maleate coadministered on day 10 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyrotinib maleate | Drug | a single oral dose of pyrotinib maleate on day 1 & day10 . |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of pyrotinib | Peak Plasma Concentration (Cmax) of pyrotinib | through study completion, an average of 20 days |
| Pharmacokinetics parameter: AUC of pyrotinib | Area under the plasma concentration versus time curve (AUC) of pyrotinib | through study completion, an average of 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Tmax of pyrotinib | Time of maximum observed concentration (Tmax) of pyrotinib | through study completion, an average of 20 days |
| Pharmacokinetics parameter: T1/2 of pyrotinib |
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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 |
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| ID | Term |
|---|---|
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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single arm, open and fixed sequence
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| Loperamide |
| Drug |
Loperamide 4 mg bid from day 7 to day 13 |
|
Time of maximum observed concentration (Tmax) of pyrotinib
| through study completion, an average of 20 days |
| Pharmacokinetics parameter: CL/F of pyrotinib | Total body clearance for extravascular administration (CL/F) of pyrotinib | through study completion, an average of 20 days |
| Pharmacokinetics parameter: Vz/F of pyrotinib | Volume of distribution (Vz/F) of pyrotinib | through study completion, an average of 20 days |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | An adverse event is any untoward medical occurrence in a patient or clinical study participant | through study completion, an average of 20 days |