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Formulation C ODT

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials 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

Formulation C ODT clinical trials

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
Healthy VolunteersUnlock trial analytics

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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Frequently asked questions about Formulation C ODT

What is Formulation C ODT?

Formulation C ODT is an oral disintegrating tablet formulation developed by Pfizer, Inc. (PFE). It is a small molecule product candidate that has been studied in a Phase 1 clinical trial. The tablet is also known as Formulation C ODT tablet 50 mg.

Who makes Formulation C ODT?

Formulation C ODT is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer of this oral disintegrating tablet formulation.

What phase is Formulation C ODT in?

Formulation C ODT is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any ongoing trials. It is an investigational formulation and has not been approved by the FDA.

What clinical trials is Formulation C ODT in?

Formulation C ODT has been studied in one completed Phase 1 clinical trial, NCT00950404, titled "Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet." The trial enrolled 16 healthy adult volunteers in the United States and used an active-controlled, randomized design.