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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | randomized sequence of current low dose formulation (3 tablets) and high dose (1 tablet) BILR 355 BS 1B formulation, separated by 14-day washout |
|
| Group B | Experimental | randomized sequence of BILR 355 BS (JM) + SDS formulation low dose (2 tablets) ,BILR 355 BS (HM) + SDS formulation low dose (2 tablets), BILR 355 BS high dose 1B formulation (4 low dose tablets), separated by 14-day washout |
|
| Group C | Experimental | randomized sequence of BILR 355 BS (JM) + SDS formulation high dose (4 tablets) , BILR 355 BS (JM) + SDS formulation mid dose (3 tablets), BILR 355 BS (HM) + SDS formulation high dose (4 tablets), separated by 14-day washout |
|
| Group D | Experimental | randomized sequence of BILR 355 BS Suspension high dose, BILR 355 BS Suspension low dose, current low dose BILR 355 BS 1B formulation (3 tablets) separated by 14-day washout |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILR 355 BS /1B, current low dose formulation | Drug |
| ||
| BILR 355 BS /1B, current high dose formulation |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (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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Exclusion Criteria:
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|
| Drug |
|
| BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation | Drug |
|
| BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation | Drug |
|
| BILR 355 BS - Suspension low dose | Drug |
|
| BILR 355 BS - Suspension high dose | Drug |
|
| Ritonavir | Drug |
|
| Up to 96 hours after drug administration |
| λz (terminal rate constant in plasma) | Up to 96 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | Up to 96 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after po administration) | 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 |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | Up to 96 hours after drug administration |
| Number of participants with clinically significant changes in vital signs | Up to day 43 after first drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to day 43 after first drug administration |
| Number of participants with Adverse Events | Up to day 43 after first drug administration |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D012967 | Sodium Dodecyl Sulfate |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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