NCT01163630

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.

Conditions

• Effect of Food
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	esomeprazole/ASA Fixed Dose Combination (FDC)	esomeprazole 20 mg/ASA 81 mg oral capsule

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-07-16
• Last updated: 2010-12-07

Locations

1 site across 1 country: United States