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Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of Combivir® on BILR 355 BS pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combivir® plus BILR 355/Ritonavir | Experimental |
| |
| BILR 355/Ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS | Drug |
| ||
| Combivir® |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over one dosing interval at steady state (AUC0-12h,ss) | up to day 18 | |
| Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss) | up to day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | up to day 18 | |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Drug |
|
| Ritonavir | Drug |
|
|
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to day 18 |
| Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/Fss) | up to day 18 |
| Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h, ss) | up to day 18 |
| Number of subjects with adverse events | up to 49 days |
| Number of subjects with abnormal laboratory parameters | up to 49 days |
| Number of subjects with clinically significant findings in vital signs | up to 49 days |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |