Skip to main content
OpenTrials
Completed

NCT Number: NCT03225352

A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate Pain

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bio-Images Research Ltd

Glasgow, Glasgow City, G4 0SF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 mg acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Single intake of 1 tablet, 500mg

1000 mg acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Single intake of 1 tablet, 1000mg

400 mg ibuprofen(Nurofen)

Drug

Single intake of 1 tablet, 400mg

400 mg ibuprofen (Dolormin Extra)

Drug

Single intake of 1 tablet, 400mg

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.