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| Name | Class |
|---|---|
| Ascletis Pharmaceuticals Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fasting group | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition. For group1: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group2: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
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| Fed group | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition. For group3: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group4: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir for cycle1 and NORVIR for cycle 2 | Drug | During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 . |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for ritonavir Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | 36 hours post-dose on Day 1,7 |
| Tmax | Time to Reach the Maximum Plasma Concentration | 36 hours post-dose on Day 1,7 |
| AUC(0-inf) | Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir | Time Frame: 36 hours post-dose on Day 1,7 |
| AUC(0-36h) | Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir | 36 hours post-dose on Day 1,7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| NORVIR for cycle 1 and Ritonavir for cycle 2 | Drug | During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 . |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |