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Pharmacokinetic Study Comparing Aspirin and Aspirin Granules

NCT01072604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-21

No results posted yet for this study

Summary

To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects

Conditions

  • Pharmacokinetics

Interventions

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

One oral dose of new formula Aspirin Prototype 1 under fasting conditions

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

One oral dose of new formula Aspirin Prototype 2 under fasting conditions

DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

One oral dose of Aspirin Plain Tablet under fasting conditions

DRUG

Acetylsalicylic acid (Aspirin, BAYE4465)

One oral dose of Aspirin Dry Granules under fasting conditions

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072604 on ClinicalTrials.gov