A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

Moderate Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225352
• Other study ID #: 19220
• Secondary ID: 2016-004546-29
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2017
• Est. completion date: October 16, 2017

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 16, 2017
• Est. primary completion date: October 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Moderate Pain

Intervention

Drug:
• 500 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 500mg
• 1000 mg acetylsalicylic acid (Aspirin, BAYE4465)
Single intake of 1 tablet, 1000mg
• 400 mg ibuprofen(Nurofen)
Single intake of 1 tablet, 400mg
• 400 mg ibuprofen (Dolormin Extra)
Single intake of 1 tablet, 400mg

Locations

Country	Name	City	State
United Kingdom	Bio-Images Research Ltd	Glasgow	Glasgow City

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 4 hours
Secondary	Gastric empty time, if applicable	Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images	Up to 4 hours
Secondary	Time of colon arrival, if applicable	Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images	Up to 4 hours
Secondary	Small intestine transit time, if applicable	Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	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	Up to 4 hours
Secondary	AUC0-t	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
Secondary	Cmax	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
Secondary	AUC0-infinity	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
Secondary	t1/2	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
Secondary	tmax	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
Secondary	Cmax/AUC0-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