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The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.
A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BILR 355 (dose escalation) + Ritonavir | Experimental | escalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 - D1 | Drug |
| ||
| BILR 355 - D2 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 120 hours after drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 120 hours after drug administration | |
| AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) | up to 120 hours after drug administration | |
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 120 hours after drug administration | |
| Tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 120 hours after drug administration | |
| t½ (Terminal half-life of the analyte in plasma) | up to 120 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 10 days after last dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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|
| BILR 355 - D3 | Drug |
|
| BILR 355 - D4 | Drug |
|
| Ritonavir | Drug |
|
| high fat breakfast | Other |
|
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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