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This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011 Capsules. A total of 15 healthy participants are planned to be enrolled. Participants will be randomized to Sequence A, Sequence B or Sequence C at a 1:1:1 ratio and receive a single oral dose of ABSK-011 (50 mg × 4) on three separate occasions with a 4-day washout interval between administrations. 39 PK blood sampling time points will be collected in Part A.
Part B is a single-center, open-label, fixed-sequence study designed to assess the impact of multiple oral doses of omeprazole enteric-coated tablets on the pharmacokinetic profiles of ABSK-011 Capsules. 15 healthy participants are planned for enrollment. On Day 1 of Cycle 1 (C1D1), participants will receive 200 mg ABSK-011 Capsules in the morning after a low-fat meal. From Day 1 to Day 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. 26 PK blood sampling time points will be collected in Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Participants in Sequence A will receive 200 mg ABSK-011 Capsules orally under fasted conditions on the morning of Day 1 of Cycle 1 (C1D1), followed by 200 mg ABSK-011 Capsules after a low-fat meal on the morning of Day 1 of Cycle 2 (C2D1), and 200 mg ABSK-011 Capsules after a high-fat meal on the morning of Day 1 of Cycle 3 (C3D1). |
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| Sequence B | Experimental | Participants in Sequence B will receive 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C2D1, and 200 mg ABSK-011 Capsules under fasted conditions on the morning of C3D1. |
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| Sequence C | Experimental | Participants in Sequence C will receive 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules under fasted conditions on the morning of C2D1, and 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C3D1. |
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| Omeprazole + Low-Fat Meal + ABSK-011 | Experimental | Participants will receive 200 mg ABSK-011 Capsules following a low-fat meal on the morning of Day 1 of Cycle 1 (C1D1). During Days 1 to 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. On C2D5, a low-fat meal will be provided 1.5 hours (±1 minute) after omeprazole administration, and a single oral dose of 200 mg ABSK-011 Capsules will be administered 2 hours (±1 minute) after omeprazole intake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSK-011 Capsules | Drug | ABSK-011 Capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Peak concentration, the maximum observed plasma concentration of ABSK-011 | pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) | Area under the plasma concentration-time curve from time 0 to infinity of ABSK-011 | pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours |
| Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) | Area under the plasma concentration-time curve from time 0 to the last measurable concentration of ABSK-011 | pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours |
| Time to maximum plasma concentration (tmax) | Time to maximum plasma concentration of ABSK-011 | pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuqi Zeng, Doctor | Contact | +86-021-68910052 | clinical@abbisko.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yiqing Zhao, Bachelor | Affiliated Hospital of Jiangnan University | Principal Investigator |
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| omeprazole enteric-coated tablets | Drug | ABSK-011 Capsules、omeprazole enteric-coated tablets |
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