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Alka Seltzer Extra Strength

Phase 1

Pharmacokinetics | Small molecule | Other |Bayer AG|Last Updated: Jun 26, 2014

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

Clinical trial landscape

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
Pharmacokinetics
NCT0108135326
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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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