Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX-7101A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX-7101A 80mg | Drug | a drug to treatment influenza in Chinese adults |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative recovery of total radioactive material in urine and feces | The total radioactivity in excreta of healthy subjects after oral administration of [14C]ZX-7101A | From 1 days before medication to 22 days after medication |
| Cmax of total radioactivity in plasma | The peak concentration of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects | From 1 days before medication to 22 days after medication |
| AUC of total radioactivity in plasma | The area under curve of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects | From 1 days before medication to 22 days after medication |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | The Treatment-Related Adverse Events of ZX-7101A will be evaluated by the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline. | From medication to 22 days after medication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| liyan Miao, doctor | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |