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ODT #1 without 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

ODT #1 without 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
Healthy Volunteers
NCT0087180620
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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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