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| Name | Class |
|---|---|
| Ascletis Pharmaceutical Co., Ltd. | UNKNOWN |
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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 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 condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: Ritonavir tablet 100mg cylcle 2 Drug: NORVIR tablet 100mg cylcle 3 Drug: Ritonavir tablet 100mg cylcle 4 Drug: NORVIR tablet 100mg |
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| group 2 | Experimental | During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: NORVIR tablet 100mg cylcle 2 Drug: Ritonavir tablet 100mg cylcle 3 Drug: NORVIR tablet 100mg cylcle 4 Drug: Ritonavir tablet 100mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir Tablet 100mg | Drug | Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd. |
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| 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 1,7,13 and 19 |
| Tmax | Time to Reach the Maximum Plasma Concentration | 36 hours post-dose on Day 1,7,13 and 19 |
| AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir | AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity | Time Frame: 36 hours post-dose on Day 1,7,13 and 19 |
| AUC(0-36h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir | AUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose. | 36 hours post-dose on Day 1,7,13 and 19 |
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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 | ||
| First affiliated hospital of Zhejiang University |
There is no plan to make individual participant data (IPD) available to other researchers
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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 tablet 100mg | Drug | NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study. |
|
| Hanzhou |
| Zhejiang |
| 310003 |
| China |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |