A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

June 4, 2018 updated by: Bayer

An Open Label, Randomized, Four-Way Crossover Trial to Assess the Disintegration, Gastric Emptying and Pharmacokinetic Parameters of a New Disintegrating Acetylsalicylic Acid 500 mg, 1000 mg Tablet Formulation and 2 Different Ibuprofen Tablets in Fasted Healthy Male Subjects

The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G4 0SF
        • Bio-Images Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers aged 18 to 65 years included
  • Verified diagnosis of "healthy"
  • Non-smokers or passive smokers
  • BMI in the range of 18.5 to 30 kg/m2
  • Subject has given written informed consent to participate in the trial prior to admission to the trial

Exclusion Criteria:

  • Blood donation within the last 90 days prior to planned randomization
  • Any previous medication within 10 days before the planned administration of the radiolabelled Investigational Medicinal Product (rIMP) which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety
  • Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area which, in the opinion of the physician responsible, could affect the study conduct.
  • Vegetarian
  • Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 Millisievert), or will exceed 10 Millisievert over any three year period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1: starting with BAYE4465 500 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
Drug: 400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
Drug: 400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Experimental: Sequence 2: starting with BAYE4465 1000 mg
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
Drug: 400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
Drug: 400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Experimental: Sequence 3: starting with Nurofen
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
Drug: 400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
Drug: 400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg
Experimental: Sequence 4: starting with Dolormin Extra
Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design
Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
Drug: 400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
Drug: 400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to complete tablet disintegration
Time Frame: Up to 4 hours
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
Up to 4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastric empty time, if applicable
Time Frame: Up to 4 hours
Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Time of colon arrival, if applicable
Time Frame: Up to 4 hours
Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Small intestine transit time, if applicable
Time Frame: Up to 4 hours
Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Time of onset of release of radiolabel
Time Frame: Up to 4 hours
Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Site of onset of release of radiolabel
Time Frame: Up to 4 hours
Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Up to 4 hours
Site of completion of release of radiolabel
Time Frame: Up to 4 hours
Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Up to 4 hours
Disintegration rate of the tablet estimated from the radioactivity remaining
Time Frame: Up to 4 hours
Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Time of 50% disintegration of the tablet estimated from the radioactivity remaining
Time Frame: Up to 4 hours
Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
Time Frame: Up to 4 hours
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy images
Up to 4 hours
AUC0-t
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Area under the plasma concentration vs time curve from zero to the last data point
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Maximum drug concentration in plasma after single dose administration
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
AUC0-infinity
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Area under the plasma concentration vs time curve from zero to infinity
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
t1/2
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Half-life associated with the terminal slope
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
tmax
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Time to reach maximum drug concentration in the measured
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax/AUC0-infinity
Time Frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19220 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • 2016-004546-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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