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
Not provided
Not provided
To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequence 1 | Experimental | Period 1: study of ZSP1273's pharmacokinetics at steady stateï¼› Period 2: study of Oseltamivir's pharmacokineticsat at steady stateï¼› Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state. |
|
| sequence 2 | Experimental | Period 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state. |
|
| sequence 3 | Experimental | Period 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1273 | Drug | ZSP1273 tablets 600mg administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics | Tmax | pre-dose and up to 72hours post-dose |
| Plasma pharmacokinetics | t1/2 | pre-dose and up to 72hours post-dose |
| Plasma pharmacokinetics | Cmax | pre-dose and up to 72hours post-dose |
| Plasma pharmacokinetics | AUC0-∞ | pre-dose and up to 72hours post-dose |
| Plasma pharmacokinetics | CL/F | pre-dose and up to 72hours post-dose |
| Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) | TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug. | up to 37days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39992105 | Derived | Pang Y, Li H, Chen X, Cao Y, Jiang H, Huang J, Liu Y. A phase I, single-center, randomized, open-label, three-period crossover study to evaluate the drug-drug interaction between ZSP1273 and oseltamivir in healthy Chinese subjects. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0172924. doi: 10.1128/aac.01729-24. Epub 2025 Feb 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oseltamivir | Drug | Oseltamivir 75mg administered orally twice daily |
|
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |