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Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D1 | Experimental |
| |
| D2 | Experimental |
| |
| D3 | Experimental |
| |
| D4 | Experimental |
| |
| D5 | Experimental |
| |
| D6 | Experimental |
| |
| D7 | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS, D1 | Drug |
| ||
| BILR 355 BS, D2 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of the analyte in plasma (Cmax) | up to 120 hours after drug administration | |
| Time to reach Cmax (tmax) | up to 120 hours after drug administration | |
| Area under the concentration-time curve (AUC) | up to 120 hours after drug administration | |
| Terminal half-life of the analyte in plasma (t1/2) | up to 120 hours after drug administration | |
| Total clearance of the analyte in plasma (CL/F) | up to 120 hours after drug administration | |
| Total mean residence time (MRTtot) | up to 120 hours after drug administration | |
| Apparent volume of distribution (Vz/F) | up to 120 hours after drug administration | |
| Renal clearance (CLR) | up to 72 hours after drug administration | |
| Urinary excretion (Ae) | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 26 days |
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Inclusion Criteria:
Exclusion Criteria:
Following exclusion criteria are of special interest for this study:
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| D8 |
| Experimental |
|
| D10 | Experimental |
|
| Placebo | Placebo Comparator | for D3 - D10 |
|
|
| BILR 355 BS, D3 | Drug |
|
| BILR 355 BS, D4 | Drug |
|
| BILR 355 BS, D5 | Drug |
|
| BILR 355 BS, D6 | Drug |
|
| BILR 355 BS, D7 | Drug |
|
| BILR 355 BS, D8 | Drug |
|
| BILR 355 BS, D10 | Drug |
|
| Placebo | Drug |
|
| high-fat breakfast | Other |
|
| Ritonavir | Drug |
|
| 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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