At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 51 enrolled
Drug / intervention
Itraconazole +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin in Healthy Male and Female Subjects (Open-label, Fixed-sequence)
In Brief
A Phase 1 clinical trial evaluating Itraconazole, Atorvastatin, and 2 other interventions for Healthy. Completed, enrolled 51 participants across 1 site.
Detailed Summary
To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionMar 2013
TodayJul 2026
First PostedFeb 21, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.4 years ago
Interventions
Itraconazoledrug
twice daily
Atorvastatindrug
single dose
Faldaprevirdrug
once daily
Rosuvastatindrug
single dose
Faldaprevirdrug
once daily