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The purpose of this phase I study is to evaluate the food effect on the PKs of AND017 following oral single-dose administration in healthy non-elderly Chinese subjects.
This is a single-center, randomized, open-label, two-sequence, two-period crossover study in healthy non-elderly Chinese subjects to evaluate the food effect on the pharmacokinetics, as well as PD and safety of AND017 following oral single-dose administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AND017: Fasted - Fed | Experimental | Subjects were randomized to receive single dose of AND017 under fasted condition in Period 1 and under fed condition in Period 2 |
|
| AND017: Fed - Fasted | Experimental | Subjects were randomized to receive single dose of AND017 under fed condition in Period 1 and under fasted condition in Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AND017 | Drug | AND017 oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for AND017 | Day 1 and Day 6, 0-72 hours post-dose |
| AUC0-inf | Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for AND017 | Day 1 and Day 6, 0-72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusha Zhu, MD PhD | Kind Pharmaceuticals LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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