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The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390、efavirenz | Drug | SHR6390 tablet single dose;Efavirenz single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose. | from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose |
| Cmax | Maximum observed serum concentration (Cmax)for SHR6390 after Single dose. | from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose |
| AUC0-t | Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose. | from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose |
| AUC0-inf | Area under the plasma concentration versus time curve (AUC0-inf ) for SHR6390 after Single dose. | from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose |
| T1/2 | Time to elimination half-life (T1/2) for for SHR6390 after Single dose. | from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and severity of adverse events | from Day 1 to Day 34 after the first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Beijing, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39050802 | Derived | Wang J, Hu C, Zhang L. Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers. Drug Des Devel Ther. 2024 Jul 19;18:3113-3119. doi: 10.2147/DDDT.S468478. eCollection 2024. |
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The study is a single-center, open, single-dose, self-controlled clinical trial.
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