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Rifaximin Novel Formulation

Phase 1

Healthy Volunteers | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: Jun 18, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

Rifaximin Novel Formulation · 1 trial · 1 indication

Phase 1 1
NCT04529811Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy VolunteersHealthy Volunteers
COMPLETED124 Analytics
PHASE1COMPLETED
Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Percentage of participants with adverse events
Up to 18 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Formulation 1 - Low DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - Mid DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - High DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - Max DoseEXPERIMENTALRifaximin Formulation 1 Capsules
Formulation 1 Capsules - PlaceboPLACEBO_COMPARATORPlacebo Formulation 1 Capsules
Formulation 2 - Low DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2- Mid DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - High DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - Max DoseEXPERIMENTALRifaximin Formulation 2 Capsules
Formulation 2 - PlaceboPLACEBO_COMPARATORPlacebo Formulation 2 Capsules
Formulation 3 - Low doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - Mid doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - High doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - Max doseEXPERIMENTALRifaximin Formulation 3 Capsules
Formulation 3 - PlaceboPLACEBO_COMPARATORPlacebo Formulation 3 Capsules

Interventions

NameTypeDescription
Rifaximin Novel FormulationDRUGRifaximin Novel Formulation
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The participant has the ability and willingness to sign a written informed consent, is either male or female aged between 18 and 65 years, inclusive, at the time of informed consent, is in good general health, and has a body mass index (BMI) at least 18 kg/m2 and at most 34 kg...

Countries:New Zealand
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Frequently asked questions about Rifaximin Novel Formulation

What is Rifaximin Novel Formulation used for?

Rifaximin Novel Formulation is an investigational small molecule being studied in healthy volunteers. It is a novel formulation of rifaximin, an antibiotic, and is currently in Phase 1 clinical development. The drug is being evaluated for safety and pharmacokinetics, not for a specific disease indication.

Who makes Rifaximin Novel Formulation?

Rifaximin Novel Formulation is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting Phase 1 clinical trials to evaluate the safety and pharmacokinetics of this novel formulation of rifaximin in healthy volunteers.

What phase is Rifaximin Novel Formulation in?

Rifaximin Novel Formulation is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and pharmacokinetic profile.

What clinical trials is Rifaximin Novel Formulation in?

Rifaximin Novel Formulation has one completed Phase 1 clinical trial, NCT04529811, titled 'Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers.' The trial enrolled 124 participants in New Zealand and was placebo-controlled, though not double-blinded.

Is Rifaximin Novel Formulation the same as rifaximin?

Rifaximin Novel Formulation is a novel formulation of rifaximin, an antibiotic. While it contains the same active ingredient, the formulation is modified, which may affect its pharmacokinetics. The drug is being studied in healthy volunteers to evaluate these differences.