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To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS | Drug |
| ||
| Ritonavir (RTV) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss) | Up to 12 h after the last drug administration of BILR 355 | |
| Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | Up to 96 h after the last drug administration of BILR 355 | |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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NORVIR® |
|
| Kaletra® | Drug | (lopinavir (LPV) and ritonavir (RTV)) |
|
| Up to 96 h after the last drug administration of BILR 355 |
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV | Up to 12 h after RTV administration |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV | Up to 96 h after the last drug administration of BILR 355 |
| Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss) | Up to 12 h after the last drug administration of BILR 355 |
| Number of participants with Adverse Events | Up to day 35 after first drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to day 35 after first drug administration |
| Number of participants with abnormal findings in physical examination | Up to day 35 after first drug administration |
| Number of participants with clinically significant changes in vital signs | Up to day 35 after first drug administration |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |