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Alka Seltzer Extra Strength

Phase 1

Undisclosed | Small molecule | Other |Bayer AG|Trials Updated: Jun 26, 2014

Alka Seltzer Extra Strength development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Alka Seltzer Extra Strength clinical trials

Alka Seltzer Extra Strength · 1 trial · 1 indication

Phase 1 1
NCT01081353Pharmacokinetic Study Comparing Aspirin and Effervescent AspirinPharmacokinetics
COMPLETED26 Analytics
PHASE1COMPLETED
Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)
24 hours

Secondary Endpoints

Adverse event collection
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -
Arm 4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Acetylsalicylic Acid (Aspirin BAY1019036)DRUGOne tablet of new formula Aspirin under fasting conditions
Alka Seltzer Extra StrengthDRUGOne effervescent tablet under fasting conditions
Aspirin MigraineDRUGOne effervescent tablet under fasting conditions
Aspirin AsproDRUGOne effervescent tablet under fasting conditions
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs) * Results of screening and clinical laboratory tests are within normal range or considered not clini...

Countries:United States
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Frequently asked questions about Alka Seltzer Extra Strength

What is Alka Seltzer Extra Strength?

Alka Seltzer Extra Strength is an effervescent aspirin product developed by Bayer AG. It is a small molecule formulation studied for pharmacokinetics, the way the body absorbs, distributes, and clears the drug. The product is associated with the Alka Seltzer brand, which is marketed by Bayer.

Who makes Alka Seltzer Extra Strength?

Alka Seltzer Extra Strength is made by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the developer associated with this effervescent aspirin product.

What phase is Alka Seltzer Extra Strength in?

Alka Seltzer Extra Strength has been studied in a Phase 1 clinical trial. The single registered trial is completed, so no active trials are ongoing. It is an investigational formulation in clinical development rather than a newly approved product.

What clinical trials is Alka Seltzer Extra Strength in?

Alka Seltzer Extra Strength has been evaluated in one completed Phase 1 trial, NCT01081353, titled Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin. The trial enrolled 26 healthy adult volunteers in the United States, was randomized and active controlled, and was not double blind.

How does Alka Seltzer Extra Strength work?

Alka Seltzer Extra Strength is a small molecule effervescent aspirin formulation. Its pharmacokinetic profile was compared with that of plain aspirin in a Phase 1 study, meaning the trial measured how the body processes the drug rather than testing it against a disease.