check_circleStudy Completed

Pharmacokinetics

Pharmacokinetic study comparing Aspirin and Effervescent Aspirin

Trial purpose

To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

Trial summary

Enrollment Goal
26
Trial Dates
February 2010 - March 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Frontage Laboratories, LLCHackensack, 07601, United States

Primary Outcome

  • Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin)
    date_rangeTime Frame:
    24 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    24 hours
    enhanced_encryption
    Safety Issue:
    yes

Trial design

An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4