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Aleve

Phase 1

Pain | Small molecule | Pain |Bayer AG|Last Updated: Sep 15, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Aleve · 1 trial · 1 indication

Phase 1 1
NCT02549469Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times DailyPain
COMPLETED32 Analytics
PHASE1COMPLETED
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Pain
NCT0254946932
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Study Endpoints

Primary Endpoints

Cmax (maximum plasma concentration) for naproxen sodium
Days 0, 1, 2, and 3
AUC0-24 (partial area under the curve ) for naproxen sodium
Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium
Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium
Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium
Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium
Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium
Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium
Days 0, 1, 2, and 3
λz (terminal elimination rate constant)
Days 0, 1, 2, and 3
t1/2 (terminal half life)
Days 0, 1, 2, and 3

Secondary Endpoints

Adverse events (AEs) collection
up to 50 days
Serious adverse events (SAEs) collection
up to 50 days
Vital signs: sitting blood pressure
up to 50 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Naproxen sodium extended release 660 mg, 20% HPMCEXPERIMENTALBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet
Naproxen sodium extended release 660 mg, 30% HPMCEXPERIMENTALBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet
Naproxen sodium extended release 660 mg, 40% HPMCEXPERIMENTALBioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet
Naproxen sodium 220 mgACTIVE_COMPARATORBioequivalence in healthy adult subjects in a fasted state

Interventions

NameTypeDescription
Naproxen Sodium ER (BAY117031), 20% HPMCDRUG1 tablet 660 mg administered orally once daily
Naproxen Sodium ER (BAY117031), 30% HPMCDRUG1 tablet 660 mg administered orally once daily
Naproxen Sodium ER (BAY117031), 40% HPMCDRUG1 tablet 660 mg administered orally once daily
Aleve (Naproxen Sodium, BAY117031)DRUG1 tablet 220 mg administered orally three times daily
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive * Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight \>50 kg (110 lbs) * Results of screening and clinical laboratory tests are within normal limits or considered not c...

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Frequently asked questions about Aleve

What is Aleve used for?

Aleve is a small molecule drug used for the treatment of pain. It is being developed by Bayer AG. The drug is currently in Phase 1 clinical development, and it is not yet approved by the FDA.

Who makes Aleve?

Aleve is developed by Bayer AG, which is publicly traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for the treatment of pain.

What phase is Aleve in?

Aleve is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA. The drug is being studied for the treatment of pain.

What clinical trials is Aleve in?

Aleve has one completed clinical trial, NCT02549469, which was a Phase 1 study titled "Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily." The trial enrolled 32 participants and was active-controlled.

Is Aleve the same as naproxen sodium?

Aleve is a brand name for naproxen sodium, a nonsteroidal anti-inflammatory drug used to treat pain. The clinical trial for Aleve compared an extended release 660 mg tablet of naproxen sodium to a 220 mg tablet taken three times daily.