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Formulation 1

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 6, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT01351129Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration versus time profile (AUC)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Secondary Endpoints

Max observed plasma concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Time of Cmax (Tmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Concentration at 24 hours postdose (C24hr)
24 hrs postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Formulation 1EXPERIMENTAL -
Formulation 2EXPERIMENTAL -
Formulation 3EXPERIMENTAL -

Interventions

NameTypeDescription
Formulation 1DRUG150-mg immediate release tablet (single dose)
Formulation 2DRUG150-mg modified release capsule, short duration (single dose)
Formulation 3DRUG150-mg modified release capsule, long duration (single dose)
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. Exclusion...

Countries:Singapore
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Frequently asked questions about Formulation 1

What is Formulation 1 used for?

Formulation 1 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics. The drug is not approved for any indication and remains under investigation.

Who makes Formulation 1?

Formulation 1 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is Formulation 1 in?

Formulation 1 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers to assess its pharmacokinetics. One Phase 1 trial has been completed.

What clinical trials is Formulation 1 in?

Formulation 1 has one completed clinical trial, NCT01351129, titled "Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers." This Phase 1 study enrolled 12 participants in Singapore and was a controlled, randomized trial.

Is Formulation 1 the same as PF-04991532?

Yes, Formulation 1 is a formulation of PF-04991532. The completed clinical trial NCT01351129 compared the pharmacokinetics of three different formulations of PF-04991532, including Formulation 1, in healthy volunteers.