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Varenicline Controlled Release

Phase 1

Pharmacokinetics | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jan 11, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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
Pharmacokinetics
NCT0073156224
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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 used for?

Varenicline Controlled Release is a small molecule being studied for pharmacokinetics, specifically to investigate how food affects the absorption of a controlled release formulation. The clinical trial also lists smoking cessation as a condition, though the primary focus is on bioavailability and pharmacokinetic parameters.

Who makes Varenicline Controlled Release?

Varenicline Controlled Release is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical research on this controlled release formulation of varenicline, which is a small molecule therapeutic.

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 regulatory authorities. The single Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Varenicline Controlled Release in?

Varenicline Controlled Release has one completed Phase 1 trial, NCT00731562, titled 'An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation.' This trial enrolled 24 participants in the United States and studied healthy volunteers aged 18 years and older.

Is Varenicline Controlled Release the same as varenicline?

Varenicline Controlled Release is a controlled release formulation of varenicline, the active ingredient. The trial NCT00731562 investigates the effects of food on the absorption of this specific formulation, distinguishing it from immediate release versions of varenicline.