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The study will be divided into 2 parts. The first part is a relative bioavailability study of HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1-Group A | Experimental | Subjects will receive 200 mg HA121-28 tablet A on Day 1 of the first cycle, followed by tablet B on Day 36 of the second cycle, in the fasted state. |
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| Part 1-Group B | Experimental | Subjects will receive 200 mg HA121-28 tablet B on Day 1 of the first cycle, followed by tablet A on Day 36 of the second cycle, in the fasted state. |
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| Part 2-Group C | Experimental | Subjects will receive 200 mg HA121-28 tablet B on Day1 of the first cycle in fasted state, followed by tablet B on Day 36 of the second cycle in the fed state. |
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| Part 2-Group D | Experimental | Subjects will receive 200 mg HA121-28 tablet B on Day 1 of the first cycle in the fed state, followed by tablet B on Day 36 of the second cycle in fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HA121-28 tablet B | Drug | HA121-28 tablet B 200 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf). | AUCinf (unit: ng*h/mL)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf) | predose (0)~288 hours post-dose |
| Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast). | AUC0-last(unit: ng*h/mL)=Area under the plasma concentration time-curve from zero to the last measured concentration | predose (0)~288 hours post-dose. |
| Pharmacokinetics (PK) of HA121-28 in plasma: Maximum concentration (Cmax) | Cmax(ng/mL)=Maximum concentration | predose (0)~288 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered an IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610041 | China |
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| HA121-28 tablet A | Drug | HA121-28 tablet A 200 mg |
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| up to Day 51. |
| Number of participants with laboratory value abnormalities and/or adverse events (AEs) . | Number of participants with potentially clinically significant laboratory values. | up to Day 51. |
| Number of participants with vital sign abnormalities and/or adverse events (AEs) . | Number of participants with potentially clinically significant vital sign values. | up to Day 51. |
| Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) . | Number of participants with potentially clinically significant electrocardiogram (ECG) values. | up to Day 51 . |