A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

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: Completed
• Conditions: Moderate Pain
• Intervention / Treatment: Drug: 500 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 1000 mg acetylsalicylic acid (Aspirin, BAYE4465); Drug: 400 mg ibuprofen(Nurofen); Drug: 400 mg ibuprofen (Dolormin Extra)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric empty time, if applicable	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 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	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 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	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	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	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 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%)	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	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	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	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	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 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		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

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): October 7, 2017
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Ibuprofen
• Other Study ID 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