drugset / Trial / NCT02251132
Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to establish the tipranavir-ritonavir steady-state dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the short-term safety and tolerance of this drug combination will be evaluated.
Timeline
- Start
- 2000-10
- Primary completion
- 2000-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ritonavir | Other / unclassified | — | — |
| Subject | Tipranavir | Small molecule | — | — |
| Background | Erythromycin | Small molecule | — | — |
Indications
No indication recorded.