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Acetylsalicylzuur Apotex Cardio

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: May 10, 2012

Acetylsalicylzuur Apotex Cardio development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Acetylsalicylzuur Apotex Cardio clinical trials

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
HealthyUnlock 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
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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
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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
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Frequently asked questions about Acetylsalicylzuur Apotex Cardio

What is Acetylsalicylzuur Apotex Cardio?

Acetylsalicylzuur Apotex Cardio is a small molecule drug candidate developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial involving healthy adult volunteers. The specific therapeutic indications for this asset have not been publicly disclosed.

Who makes Acetylsalicylzuur Apotex Cardio?

Acetylsalicylzuur Apotex Cardio is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical development of this small molecule asset.

What phase is Acetylsalicylzuur Apotex Cardio in?

Acetylsalicylzuur Apotex Cardio is in Phase 1 clinical development. It is an investigational drug candidate and has completed one Phase 1 trial. No Phase 2 or later-stage trials for this asset have been recorded.

What clinical trials is Acetylsalicylzuur Apotex Cardio in?

Acetylsalicylzuur Apotex Cardio has been evaluated in one completed Phase 1 trial, NCT01448031, titled A Healthy Female and Male Volunteers Aspirin Study. The trial enrolled 54 healthy volunteers in the United Kingdom, used an active-controlled randomized design, and included participants aged 20 years and older.

Is Acetylsalicylzuur Apotex Cardio FDA approved?

Acetylsalicylzuur Apotex Cardio is an investigational drug candidate in Phase 1 clinical development and is not approved for marketing. Its only recorded trial, NCT01448031, has completed, and no active trials for this asset are currently listed.