check_circleStudy Completed

Moderate Pain

Bayer Identifier:

19220

ClinicalTrials.gov Identifier:

NCT03225352

EudraCT Number:

2016-004546-29

EU CT Number:

Not Available
A study to assess disintegration of the new Aspirin disintegrating tablets

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
12
Trial Dates
August 2017 - October 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bio-Images Research LtdGlasgow, G4 0SF, United Kingdom

Primary Outcome

  • Time to complete tablet disintegration
    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
    date_rangeTime Frame:
    Up to 4 hours

Secondary Outcome

  • Gastric empty time, if applicable
    Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Time of colon arrival, if applicable
    Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Small intestine transit time, if applicable
    Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Time of onset of release of radiolabel
    Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Site of onset of release of radiolabel
    Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Site of completion of release of radiolabel
    Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Disintegration rate of the tablet estimated from the radioactivity remaining
    Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Time of 50% disintegration of the tablet estimated from the radioactivity remaining
    Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
    Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy images
    date_rangeTime Frame:
    Up to 4 hours
  • AUC0-t
    Area under the plasma concentration vs time curve from zero to the last data point
    date_rangeTime 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
  • Cmax
    Maximum drug concentration in plasma after single dose administration
    date_rangeTime 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
  • AUC0-infinity
    Area under the plasma concentration vs time curve from zero to infinity
    date_rangeTime 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
  • t1/2
    Half-life associated with the terminal slope
    date_rangeTime 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
  • tmax
    Time to reach maximum drug concentration in the measured
    date_rangeTime 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
  • Cmax/AUC0-infinity
    date_rangeTime 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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4