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A study to learn how the study medicine called Ibuzatrelvir is taken up into the blood in healthy Chinese adults.
To evaluate the PK profile of ibuzatrelvir after administration in Chinese healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuzatrelvir | Experimental | Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuzatrelvir | Drug | Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | up to Day 3 | |
| AUCinf | up to Day 3 | |
| Terminal phase half-life (t½) | up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and severe adverse events | up to Day 3 | |
| Incidence of abnormal and clinically relevant changes in vital signs | up to Day 3 | |
| Incidence of abnormal and clinically relevant changes in electrocardiogram |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Up to Day 3 |
| Incidence of abnormal and clinically relevant changes in laboratory assessments | Up to Day 3 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |