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
A single-center, randomized, open, single-dose, two-cycle, two-sequence, cross-over study was conducted to evaluate the effect of food on the pharmacokinetic characteristics of GST-HG171 in combination with Ritonavir.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing. |
|
| Treatment B | Experimental | Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG171/ritonavir | Drug | Single oral dose of GST-HG171 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration (Cmax) of GST-HG171 | Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose |
| AUCinf | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171 | Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose |
| AUClast | Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171 | Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| urine | Total recovery of GST-HG171 -related substances in urine | 120 hours from GST-HG171 administration |
| feces | Total recovery of GST-HG171 -related substances in feces |
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 | 130021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| 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
| ritonavir | Drug | Single oral dose of ritonavir 100 mg at -12 hours prior to GST-HG171/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours and 24 hours after GST-HG171/ritonavir dosing. |
|
| 120 hours from GST-HG171 administration |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |