A healthy female and male volunteers aspirin study

Study identifier:D961FC00012

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product)

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Capsule ASA 81mg/esomeprazole 20mg, Acetylsalicylzuur Apotex Cardio

Sex

All

Actual Enrollment

54

Study type

Interventional

Age

20 Years - 50 Years

Date

Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Apr 2012

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria