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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

London, UK, United Kingdom

Arms	Assigned Interventions
Experimental: 1 Capsule ASA 81mg/esomeprazole 20mg	Drug: Capsule ASA 81mg/esomeprazole 20mg Multiple doses administered on Day 1 to 5
Active Comparator: 2 ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg	Drug: Acetylsalicylzuur Apotex Cardio Multiple doses administered on Day 1 to 5

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=699&filename=CSR-D961FC00012.pdf
Download
CSR-D961FC00012.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

SURESH BABU

+44 207 910 7700

Suresh.Babu@quintiles.com

Investigators

Principal Investigator

Ronnie Beboso

BioKinetic Europe Ltd,14 Great Victoria Street,Belfast, N.Ireland,United Kingdom BT2 7BA