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

Phase 1

Completed

• Conditions: Effect of Food; Pharmacokinetics
• Interventions: Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

• Registration Number: NCT01163630
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	esomeprazole/ASA Fixed Dose Combination (FDC)	esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast
2	esomeprazole/ASA Fixed Dose Combination (FDC)	esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast

Primary Outcome Measures

Name	Time	Method
To investigate the effects of food on the extent and rate of absorption of ASA and esomeprazole after a single dose administration of esomeprazole 20mg/ASA 81 mg FDC in healthy volunteers by assessment of AUC, AUC(0-t), and Cmax	Blood samples for esomeprazole analysis will be taken at predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 hours after dose adminstration

Secondary Outcome Measures

Name	Time	Method
To investigate PK of ASA and esomeprazole by assessment of tmax and t1/2λz under fed and fasting conditions.	Blood samples for ASA and SA analyses will be taken at predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 5, 6, 8, 10, 12, and 14 hours after dose administration
To investigate the PK of ASA metabolite salicylic acid (SA) by assessment of AUC, AUC(0-t), Cmax, tmax and t1/2λz under fed and fasting conditions.	Blood samples for esomeprazole analysis will be taken at predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 hours after dose adminstrationy.
To assess the safety and tolerability of esomeprazole 20mg/ASA 81 mg FDC.	AEs will be collected from the time of randomization up to and including the follow-up visit. SAEs will be recorded from the time of informed consent up to and including the follow up visit

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oveland Park, Kansas, United States