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
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | GST-HG171/ritonavir orally |
|
| Period 2 | Experimental | Itraconazole+GST-HG171/ritonavir orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG171/Ritonavir | Drug | Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GST-HG171 | The Cmax of GST-HG171 in the study was observed directly from data. | Days 2(pre-dose), 3 (pre-dose,0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24 and 48 hours postdose on Day 3) in Period 1; Days 13(pre-dose), Days 14 (pre-dose, 0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24,48, and 72 hours postdose on Day 14) of Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Screening up to Day 17 |
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 |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42112804 | Derived | Li X, Li B, Wang M, Wang J, Lu J, Mao J, Zhang T, Tang Y, Yan W, Li C, Zhang G, Ding Y. Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0028526. doi: 10.1128/aac.00285-26. Epub 2026 May 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Itraconazole | Drug | Administered orally once daily for 9 days from Days 8 through 16 |
|
| GST-HG171/Ritonavir | Drug | Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14 |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D010879 | Piperazines |