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Primary Objective :
To evaluate the effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects;
Secondary Objective:
To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-1139 tablets | Drug | Oral dose 20 mg |
| |
| Ticagrelor Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of YZJ-1139(Cmax) | To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Maximum observed concentration (Cmax). | 48 hours |
| Pharmacokinetics of YZJ-1139 (AUC0-∞) | To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) from time zero to infinity. | 48 hours |
| Pharmacokinetics of YZJ-1139 (AUC0-t) | To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and tolerability of YZJ-1139 alone and in combination with ticagrelor will be examined. | 13 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shulan (Hangzhou) Hospital | Huangzhou | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Single dose
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| Drug |
Oral dose 90 mg twice daily |
|
| D001523 |
| Mental Disorders |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |