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This trial is conducted in China. The aim of the trial is to investigate safety and efficacy of ZSP1273 granules
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSP1273 | Experimental |
| |
| Oseltamivir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1273 | Drug | Oral |
| |
| Oseltamivir |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Symptoms | Participants assessed the severity of influenza-associated symptoms | DAY1~DAY15 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of ZSP1273 | DAY1~5 | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | DAY1~15 |
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Inclusion Criteria:
Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
Participants with a diagnosis of influenza virus infection confirmed by all of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children Hospital | Beijing | China |
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| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Drug |
Oral |
|
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |