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Aciphex

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Aciphex · 1 trial · 1 indication

Phase 1 1
NCT00648349Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mgHealthy
COMPLETED72 Analytics
PHASE1COMPLETED
Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRabeprazole Sodium Delayed-Release Tablets 20 mg
2ACTIVE_COMPARATORAciphex® Delayed-Release Tablets 20 mg

Interventions

NameTypeDescription
Rabeprazole Sodium Delayed-Release Tablets 20 mgDRUG20mg, single dose fasting
Aciphex® Delayed-Release Tablets 20 mgDRUG20mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...

Countries:United States
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Frequently asked questions about Aciphex

What is Aciphex?

Aciphex is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and the therapeutic area is classified as Other.

What is Aciphex used for?

Aciphex is being studied for use in healthy individuals. It is currently in Phase 1 clinical development, with one completed trial involving 72 participants. The drug is not yet approved and remains investigational.

Who makes Aciphex?

Aciphex is developed by Viatris Inc., a company traded under the ticker symbol VTRS. The drug is currently in Phase 1 clinical development.

What phase is Aciphex in?

Aciphex is in Phase 1 clinical development. It has one completed trial with 72 enrolled participants. The drug is investigational and not yet approved for any indication.

What clinical trials is Aciphex in?

Aciphex has one completed clinical trial, NCT00648349, titled 'Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex Delayed-Release Tablets 20 mg'. This Phase 1 trial enrolled 72 healthy volunteers in the United States.

Is Aciphex the same as rabeprazole sodium?

Aciphex is being studied in comparison to rabeprazole sodium delayed-release tablets in a clinical trial. The trial NCT00648349 compares Aciphex delayed-release tablets 20 mg to rabeprazole sodium delayed-release tablets 20 mg.