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This study is a randomized, open-label, 2-period, 2-sequence, crossover food-effect study designed to evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of KH607 tablets in healthy participants, as well as to assess the safety of a single oral dose of KH607 tablets administered under fasting and fed conditions in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A: KH607 | Experimental | period 1: Fasted, Period 2: Fed |
|
| Sequence B: KH607 | Experimental | period 1: Fed, Period 2: Fasted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH607 | Drug | KH607, single dose, oral |
| |
| KH607 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Up to 96 Hours after study drug administration | |
| AUC0-∞ | Up to 96 Hours after study drug administration | |
| Cmax | Up to 96 Hours after study drug administration | |
| The GMRs and their 90% confidence intervals for AUC0-∞ (or AUC0-t and Cₘₐₓ of KH607 tablets under fasting and fed conditions ) | Up to 96 Hours after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Up to 96 Hours after study drug administration | |
| t1/2 | Up to 96 Hours after study drug administration | |
| λz |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Meng Yang, Medical Doctor | Contact | 86-28-87393401 | ymc681@126.com |
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| Drug |
KH607, single dose, oral |
|
| Up to 96 Hours after study drug administration |
| tlag | Up to 96 Hours after study drug administration |
| CL/F | Up to 96 Hours after study drug administration |
| Safety:Incidence and severity of Adverse Events ( AE)/SAE | from ICF signing date to day 19 since first dose |