Clinical trial NCT03225352: A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate Pain
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to complete tablet disintegration
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Gastric empty time, if applicable
timeFrame: Up to 4 hours
measure: Time of colon arrival, if applicable
timeFrame: Up to 4 hours
measure: Small intestine transit time, if applicable
timeFrame: Up to 4 hours
measure: Time of onset of release of radiolabel
timeFrame: Up to 4 hours
measure: Site of onset of release of radiolabel
timeFrame: Up to 4 hours
measure: Site of completion of release of radiolabel
timeFrame: Up to 4 hours
measure: Disintegration rate of the tablet estimated from the radioactivity remaining
timeFrame: Up to 4 hours
measure: Time of 50% disintegration of the tablet estimated from the radioactivity remaining
timeFrame: Up to 4 hours
measure: Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
timeFrame: Up to 4 hours
measure: AUC0-t
timeFrame: 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
measure: Cmax
timeFrame: 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
measure: AUC0-infinity
timeFrame: 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
measure: t1/2
timeFrame: 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
measure: tmax
timeFrame: 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
measure: Cmax/AUC0-infinity
timeFrame: 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
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Bio-Images Research Ltd
state: Glasgow City
Study officials:
References: