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Revatio

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 29, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Revatio · 1 trial · 1 indication

Phase 1 1
NCT01027117A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy VolunteersHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

AUClast
Within 14 hours post dose
Cmax
Within 14 hours post dose

Secondary Endpoints

T1/2
Within 14 hours post dose
AUCinf
Within 14 hours post dose
Tmax
Within 14 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AACTIVE_COMPARATORRevatio 20 mg intact tablet. This is the reference treatment arm.
Treatment BEXPERIMENTALTreatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
Treatment CEXPERIMENTALTreatment C: Revatio 20 mg extemporaneously prepared suspension (EP).

Interventions

NameTypeDescription
RevatioDRUGThree treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and cli...

Countries:Belgium
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Frequently asked questions about Revatio

What is Revatio used for?

Revatio is a small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its bioavailability. The drug is being developed by Pfizer, Inc.

Who makes Revatio?

Revatio is being developed by Pfizer, Inc., a 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 Revatio in?

Revatio is in Phase 1 clinical development. It has one completed trial that enrolled 18 healthy volunteers. The drug is investigational and has not been approved for any indication.

What clinical trials is Revatio in?

Revatio has one completed clinical trial, NCT01027117, which was a relative bioavailability study of crushed tablets, extemporaneously prepared formulation, and intact tablets at a 20 mg dose in healthy volunteers. The trial was conducted in Belgium.

Is Revatio the same as sildenafil?

Revatio is a brand name for sildenafil, a phosphodiesterase type 5 inhibitor. The clinical trial NCT01027117 evaluated the bioavailability of Revatio tablets in healthy volunteers.