Phase 1
Completed N=25
Pharmacokinetics of Faldaprevir of Soft Capsule
Healthy
Source: ClinicalTrials.gov NCT01821937 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Cmax,ss (After Multiple Dosing) — 3270; 14200 ng/mL
Summary
The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax,ss (After Multiple Dosing) |
3270; 14200 | — |
| PRIMARY AUC(Tau,ss) (After Multiple Dosing) |
36200; 199000 | — |
| SECONDARY Cmax (After Single Dosing) |
664; 2060 | — |
| SECONDARY AUC(0-tz) (After Single Dosing) |
14600; 37900 | — |
| SECONDARY t(1/2,ss) (After Multiple Dosing) |
31.2; 20.0 | — |
| SECONDARY Tmax,ss (After Multiple Dosing) |
2.85; 2.44 | — |
Eligibility Criteria
Inclusion criteria
Healthy male and female subjects
Exclusion criteria
Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01821937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.