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Formulation C ODT

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 1, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Formulation C ODT · 1 trial · 1 indication

Phase 1 1
NCT00950404Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral TabletHealthy Volunteers
COMPLETED16 Analytics
PHASE1COMPLETED
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
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Study Endpoints

Primary Endpoints

AUC0-T and Cmax of sildenafil
1 month

Secondary Endpoints

AUC0-Tmax and AUCinf of sildenafil
1 month
Tmax and half-life of sildenafil
1 month
adverse events
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Viagra 50 mg tablet, administered with water.ACTIVE_COMPARATOR -
Formulation B ODT tablet 50 mg, administered without water.EXPERIMENTAL -
Formulation C ODT tablet 50 mg, administered without water.EXPERIMENTAL -
Formulation D ODT tablet 50 mg, administered without water.EXPERIMENTAL -

Interventions

NameTypeDescription
Viagra 50 mg tabletDRUGCommercial tablet, 50 mg, single dose administered with water
Formulation B ODT tablet 50 mgDRUGOral disintegrating tablet (ODT), 50 mg, single dose administered without water
Formulation C ODT tablet 50 mgDRUGODT, 50 mg, single dose administered without water
Formulation D ODT tablet 50 mgDRUGODT, 50 mg, single dose, administered without water
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects * Weight: BMI from 17.5 to 30.5 Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies,...

Countries:United States
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