This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
42
Fixed dose combination tablet with ritonavir, single oral dose
Reference tablet, single oral dose
Fixed dose combination tablet with danoprevir, single oral dose
Reference tablet, single oral dose
Unnamed facility
Christchurch, New Zealand
Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Safety: Incidence of adverse events
Time frame: approximately 2 months
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