Phase 1, Randomised, Placebo-Controlled, Single-Ascending Dose and Multiple-Dose with 3 novel RIFAXIMIN Formulations. 2 phases: Single-Ascending Dose (SAD) Phase and a Multiple-Dose (MD) Phase, Plus optional open-label, crossover Food Effect (FE) Evaluation Primary objective: evaluate the safety and tolerability of three novel formulations of rifaximin in healthy volunteers. Secondary objective: evaluate the pharmacokinetics (PK) of the novel formulations and to assess for the presence of exploratory biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
Rifaximin Novel Formulation
Placebo
Auckland Clinical Studies
Grafton, Auckland, New Zealand
Percentage of participants with adverse events
Time frame: Up to 18 days
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