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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01163630

Enrollment

Registered

2010-07-16

Start date

2010-06-30

Completion date

2010-09-30

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Food, Pharmacokinetics

Keywords

open label, randomized, single-center, 2-way crossover, food interaction study

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.

Interventions

DRUGesomeprazole/ASA Fixed Dose Combination (FDC)

esomeprazole 20 mg/ASA 81 mg oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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 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

Secondary

Measure	Time frame
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 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 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026