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Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP681 tablet 40mg | Experimental | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water. |
|
| GP681 tablet 20mg | Experimental | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water. |
|
| Placebo group | Placebo Comparator | Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP681 tablet | Drug | influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. |
| Measure | Description | Time Frame |
|---|---|---|
| time to alleviation of influenza symptoms | Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) . | Day 15 |
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Inclusion Criteria:
Positive Influenza rapid antigen test;
Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:
Time of disease symptoms ≤48h
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Cao, phd | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39870350 | Derived | Wang Y, Wang H, Liu D, Ding Y, Zhang M, Xiao Z, Jiang X, Wu Y, Zhang W, Sun S, Chen X, Zhang W, Tang Y, Jiang M, Yang G, Jia W, Wang X, Tong J, Suo L, Yu Y, Yan X, Li Z, Li X, Cao B. Efficacy and safety of single-dose suraxavir marboxil tablet in the treatment of acute uncomplicated influenza in adults: a multi-centre, randomized, double-blind, placebo-controlled phase 2 clinical trial. Clin Microbiol Infect. 2025 May;31(5):861-868. doi: 10.1016/j.cmi.2025.01.025. Epub 2025 Jan 25. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| GP681 Simulant | Drug | influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |