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Varenicline Controlled Release

Phase 1

Smoking Cessation | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Jan 11, 2010

Varenicline Controlled Release target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classAgonist
ModalitySmall molecule

Also known as Varenicline Tartrate Controlled Release

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Varenicline Controlled Release clinical trials

Varenicline Controlled Release · 1 trial · 3 indications

Phase 1 1
NCT00731562An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release FormulationPharmacokinetics
COMPLETED24 Analytics
PHASE1COMPLETED
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
5 days
Maximum plasma concentration of varenicline
1 day

Secondary Endpoints

Safety measures including adverse events
5 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Varenicline Controlled Release, FastedEXPERIMENTAL -
Varenicline Controlled Release, FedEXPERIMENTAL -

Interventions

NameTypeDescription
Varenicline Tartrate Controlled ReleaseDRUGA single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female adult smokers * 18 to 55 years of age Exclusion Criteria: * Sensitivity to varenicline * Illegal drug use * Pregnant or nursing females

Countries:United States
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Frequently asked questions about Varenicline Controlled Release

What is Varenicline Controlled Release?

Varenicline Controlled Release is an investigational small molecule being developed by Pfizer, Inc. (PFE) for smoking cessation. It is a controlled release formulation of varenicline tartrate, also known as Varenicline Tartrate Controlled Release. The drug is in Phase 1 clinical development.

What is Varenicline Controlled Release used for?

Varenicline Controlled Release is being developed for smoking cessation. It is intended to help people quit smoking. The drug is in Phase 1 testing and has not been approved for any indication.

What does Varenicline Controlled Release target?

Varenicline Controlled Release targets CHRNB2 and CHRNA4. It acts as an agonist at these targets. This mechanism is associated with its development for smoking cessation.

Who is developing Varenicline Controlled Release?

Pfizer, Inc. (ticker: PFE) is developing Varenicline Controlled Release. Pfizer is the company responsible for the clinical development of this controlled release formulation of varenicline tartrate.

What phase is Varenicline Controlled Release in?

Varenicline Controlled Release is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The only completed trial was a Phase 1 study.

What clinical trials is Varenicline Controlled Release in?

Varenicline Controlled Release has been studied in one completed Phase 1 trial, NCT00731562, titled "An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation." The trial enrolled 24 healthy volunteers in the United States and is now completed.

Is Varenicline Controlled Release the same as Varenicline Tartrate Controlled Release?

Yes, Varenicline Controlled Release is also known as Varenicline Tartrate Controlled Release. Both names refer to the same investigational drug being developed by Pfizer for smoking cessation.