drugset / Trial / NCT02182323
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
RandomizedParallel-groupSingle-blindTreatment
Summary
The objective of this study was to investigate the safety, tolerability, and pharmacokinetics of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg. In addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was investigated.
Timeline
- Start
- 2006-09
- Primary completion
- 2006-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Faldaprevir | Small molecule | 4 mg | — |
| Subject | Faldaprevir | Small molecule | 16 mg | — |
| Subject | Faldaprevir | Small molecule | 48 mg | — |
| Subject | Faldaprevir | Small molecule | 120 mg | — |
| Subject | Faldaprevir | Small molecule | 240 mg | — |
| Subject | Faldaprevir | Small molecule | 480 mg | — |
| Subject | Faldaprevir | Small molecule | 800 mg | — |
| Subject | Faldaprevir | Small molecule | 1200 mg | — |
Indications
No indication recorded.