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Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 - low dose | Experimental | Treatment sequences ABC / CAB / BCA |
|
| Dose Group 2 - high dose | Experimental | Treatment sequences DE / ED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 - Treatment A (current tablet formulation) | Drug |
| ||
| BILR 355 - Treatment B (new tablet formulation) |
| 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 96 hours after drug administration | |
| Cmax (maximum measured concentration of analyte in plasma) | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 96 hours after drug administration | |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| BILR 355 - Treatment C (new capsule formulation) | Drug |
|
| BILR 355 - Treatment D (current tablet formulation) | Drug |
|
| BILR 355 - Treatment E (new capsule formulation) | Drug |
|
| Ritonavir | Drug |
|
| up to 96 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 96 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 96 hours after drug administration |
| Number of subjects with adverse events | up to 12 days following last drug administration |
| Number of subjects with abnormal changes in laboratory parameters | up to 48 hours after drug administration |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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