Recent Updates
Recently added Catalysts

Acetylsalicylzuur Apotex Cardio

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 10, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Acetylsalicylzuur Apotex Cardio · 1 trial · 1 indication

Phase 1 1
NCT01448031A Healthy Female and Male Volunteers Aspirin StudyHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
A Healthy Female and Male Volunteers Aspirin Study
Healthy
NCT0144803154
Unlock trial analytics

Study Endpoints

Primary Endpoints

pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2).
Day 5

PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.

Secondary Endpoints

Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs
Pre-dose up to 7 day after last dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCapsule ASA 81mg/esomeprazole 20mg
2ACTIVE_COMPARATORASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg

Interventions

NameTypeDescription
Capsule ASA 81mg/esomeprazole 20mgDRUGMultiple doses administered on Day 1 to 5
Acetylsalicylzuur Apotex CardioDRUGMultiple doses administered on Day 1 to 5
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects aged 20 to 50 years inclusive. * Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive. * Females must be of non-childbearing potential or be of childbearing potential but have a negative serum h...

Countries:United Kingdom
Unlock Eligibility Criteria