drugset / Trial / NCT02243553
Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.
Timeline
- Start
- 2006-01
- Primary completion
- 2006-07
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | — |
| Subject | Dextromethorphan | Unknown | — | — |
| Subject | Digoxin | Other / unclassified | — | Other |
| Subject | Midazolam | Small molecule | — | Other |
| Subject | Omeprazole | Other / unclassified | — | — |
| Subject | Ritonavir | Other / unclassified | 200 mg | — |
| Subject | Tipranavir | Small molecule | 500 mg | — |
| Subject | Warfarin | Small molecule | — | — |
| Background | Vitamin K | Unknown | — | — |
Indications
No indication recorded.