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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Effect of Food; Pharmacokinetics

Treatments: Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163630

D961FC00009

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
• Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion criteria

• Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
• History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
• Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast

Treatment:

Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

2

Experimental group

Description:

esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast

Treatment:

Drug: esomeprazole/ASA Fixed Dose Combination (FDC)