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The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.
The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyrotinib maleate fasted in P1, low-fat diet in P2 | Drug | pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of pyrotinib | Peak Plasma Concentration (Cmax) of pyrotinib | through study completion, an average of 28 days |
| Pharmacokinetics parameter: AUC of pyrotinib | Area under the plasma concentration versus time curve (AUC) of pyrotinib | through study completion, an average of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Tmax of pyrotinib | Time of maximum observed concentration (Tmax) of pyrotinib | through study completion, an average of 28 days |
| Pharmacokinetics parameter: T1/2 of pyrotinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuya Wang, Ph.D. | Contact | 86-13918749176 | wangyuya@hrglobe.cn | |
| Chao Lu, M.M. | Contact | 86-18005693201 | 765385306@qq.com |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| C020845 | P-2 |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| pyrotinib maleate low-fat diet in P1, fasted in P2 | Drug | pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2 |
|
Half time (T1/2) of pyrotinib
| through study completion, an average of 28 days |
| Pharmacokinetics parameter: CL/F of pyrotinib | Total body clearance for extravascular administration (CL/F) of pyrotinib | through study completion, an average of 28 days |
| Pharmacokinetics parameter: Vz/F of pyrotinib | Volume of distribution (Vz/F) of pyrotinib | through study completion, an average of 28 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 28 days |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |