NCT01072604

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

February 19, 2010

Last Update Submit

April 18, 2014

Conditions

Pharmacokinetics

Keywords

AspirinAcetylsalicylic Acid

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (2)

  • To assess safety and tolerability of the new aspirin formula

    24 hours

  • To assess additional pharmacokinetic parameters

    24 hours

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Arm 2

EXPERIMENTAL
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)

Arm 3

ACTIVE COMPARATOR
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 4

ACTIVE COMPARATOR
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Interventions

Acetylsalicylic acid (Aspirin, BAY1019036)DRUG

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

Arm 1
Acetylsalicylic acid (Aspirin, BAYE4465)DRUG

One oral dose of Aspirin Plain Tablet under fasting conditions

Arm 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 clinically significant by the Principal Investigator or Sponsor
  • Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
  • Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

You may not qualify if:

  • History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
  • Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
  • Syndromes of asthma, rhinitis or nasal polyps
  • Females who are pregnant or lactating
  • Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
  • Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 22, 2010

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

US(1)