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Commercial with water

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 27, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Commercial with water · 1 trial · 1 indication

Phase 1 1
NCT00871806Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With WaterHealthy Volunteers
COMPLETED20 Analytics
PHASE1COMPLETED
Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
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Study Endpoints

Primary Endpoints

Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
24 hr

Secondary Endpoints

Time of peak eletriptan concentrations (Tmax), half life
24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Eletriptan commercial tablet with waterACTIVE_COMPARATOREletriptan commercial tablet given with water
Eletriptan oral disintegrating tablet (ODT) #1 without waterEXPERIMENTALOral disintegrating tablet formulation #1 without water
Oral disintegrating tablet formulation (ODT) #2 without waterEXPERIMENTALOral disintegrating tablet formulation #2 without water
Oral disintegrating tablet formulation (ODT) #1 with waterEXPERIMENTALOral disintegrating tablet formulation (ODT) #1 with water
Oral disintegrating tablet formulation (ODT) #2 with waterEXPERIMENTALOral disintegrating tablet formulation (ODT) #2 with water

Interventions

NameTypeDescription
Commercial tablet with waterDRUG40 mg tablet, given once to each subject
ODT #1 without waterDRUG40 mg tablet given once to each subject
ODT #2 without waterDRUG40 mg tablet given once to each subject
ODT #1 with waterDRUG40 mg tablet given once to each subject
ODT #2 with waterDRUG40 mg tablet given once to each subject
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects * No CYP3A4 inhibitors Exclusion Criteria: * Clinically significant disease in any organ system * Positive urine drug screen

Countries:Singapore
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Frequently asked questions about Commercial with water

What is Commercial with water?

Commercial with water is a small molecule drug being developed by Pfizer, Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being studied in a pharmacokinetic trial to evaluate its absorption and processing in the body.

What is Commercial with water used for?

Commercial with water is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with the goal of understanding how the drug behaves in the body. The specific therapeutic indication has not been established, as it is still in early-stage research.

Who makes Commercial with water?

Commercial with water is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is Commercial with water in?

Commercial with water is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated in healthy volunteers.

What clinical trials is Commercial with water in?

Commercial with water has one completed clinical trial, NCT00871806, which studied the pharmacokinetics of two eletriptan oral formulations given with and without water and the commercial tablet formulation given with water. The trial enrolled 20 healthy volunteers in Singapore.

Is Commercial with water the same as eletriptan?

Commercial with water is not the same as eletriptan. It is a formulation of eletriptan, a small molecule drug, being studied in a pharmacokinetic trial. The trial compares different oral formulations of eletriptan, including the commercial tablet, to understand their absorption when taken with or without water.