Status and phase
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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.
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Interventional model
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124 participants in 15 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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