Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers
Status:
Completed
Trial end date:
2021-05-09
Target enrollment:
Participant gender:
Summary
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.