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Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets

NCT03056703 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-02-17

No results posted yet for this study

Summary

The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release tablet and to test for bioequivalence of the new versus the commercial product in healthy adult subjects.

Conditions

Interventions

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

One Fast Release Tablet containing 1000 mg acetylsalicylic acid

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

Two Fast Release Tablets containing 500 mg acetylsalicylic acid each

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
2014-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT03056703 on ClinicalTrials.gov