Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic acid 81 mg

Study identifier:D961FC00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination capsule of Esomeprazole 20 mg/Acetylsalicylic acid 81 mg

Medical condition

Effect of Food, pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

esomeprazole/ASA Fixed Dose Combination (FDC)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Jun 2010

Primary Completion Date: 01 Sept 2010

Study Completion Date: 01 Sept 2010

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Oveland Park, KS, United States

Arms	Assigned Interventions
Experimental: 1 esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast	Drug: esomeprazole/ASA Fixed Dose Combination (FDC) esomeprazole 20 mg/ASA 81 mg oral capsule
Experimental: 2 esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast	Drug: esomeprazole/ASA Fixed Dose Combination (FDC) esomeprazole 20 mg/ASA 81 mg oral capsule

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=696&filename=CSR-D961FC00009.pdf
Download
CSR-D961FC00009.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles Overland Park Kansas

1-800-292-5533

volunteer@quintiles.com

Investigators

Principal Investigator

Kelli Craven

Quintiles