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To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new Tipranavir + Ritonavir | Experimental |
| |
| current Tipranavir + Ritonavir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tipranavir | Drug | New oral solution (back up) formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of drug in plasma over the time interval from 0 extrapolated to infinity) for tipranavir | up to 72 hours after drug administration | |
| Cmax (maximum measured concentration of drug in plasma) for tipranavir | up to 72 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ for ritonavir | up to 72 hours after drug administration | |
| Cmax for ritonavir | up to 72 hours after drug administration | |
| AUC0-tz (area under the concentration-time curve of drug in plasma over the time interval from 0 to the time of the last quantifiable data point) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| ID | Term |
|---|---|
| C107201 | tipranavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Tipranavir |
| Drug |
|
|
| Ritonavir | Drug |
|
|
| up to 72 hours after drug administration |
| tmax (time from dosing to the maximum concentration of drug in plasma) | up to 72 hours after drug administration |
| λz (terminal rate constant of drug in plasma) | up to 72 hours after drug administration |
| t1/2 (terminal half-life of drug in plasma) | up to 72 hours after drug administration |
| MRTpo (mean residence time of drug in the body after oral administration) | up to 72 hours after drug administration |
| CLpo/F (apparent clearance of drug after oral administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after drug administration |
| Number of patients with adverse events | up to 43 days |
| Number of patients with clinically significant findings in vital signs | up to 43 days |
| Number of patients with clinically significant findings in 12-lead electrocardiogram | up to 43 days |
| Number of patients with clinically significant findings in laboratory tests | up to 43 days |
| Assessment of tolerability by investigator on a 4-point scale | Day 4 of each treatment period |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |