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The study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.
Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | SHR2150+ efavirenz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2150 tablet、efavirenz | Drug | SHR2150 tablet single dose, Efavirenz single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum observed serum concentration (Tmax) for SHR2150 after Single dose | from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose |
| Cmax | Maximum observed serum concentration (Cmax) for SHR2150 after Single dose | from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose |
| AUC0-t | Area under the plasma concentration versus time curve (AUC0-t) for SHR2150 after Single dose | from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose |
| AUC0-inf | Area under the plasma concentration versus time curve (AUC0-inf ) for SHR2150 after Single dose | from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose |
| T1/2 | Time to elimination half-life (T1/2) for for SHR2150 after Single dose | from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and the severity of adverse events | from Day 1 to Day 37 after the first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | 110067 | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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The study is a single-centre, single-arm, open-label and fixed-sequence clinical trial.
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |