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

Purpose

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.

Condition	Intervention	Phase
Effect of Food Pharmacokinetics	Drug: esomeprazole/ASA Fixed Dose Combination (FDC)	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Aspirin Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
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 [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate PK of ASA and esomeprazole by assessment of tmax and t1/2λz under fed and fasting conditions. [ Time Frame: 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 ] [ Designated as safety issue: No ]
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. [ Time Frame: 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 ] [ Designated as safety issue: No ]
To assess the safety and tolerability of esomeprazole 20mg/ASA 81 mg FDC. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	June 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163630

Locations

United States, Kansas
Research Site
Oveland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Kelli Craven, MD	Quintiles
Study Director:	Ken Price	AstraZeneca
Study Director:	Mirjana Kujacic	AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01163630 History of Changes
Other Study ID Numbers:	D961FC00009
Study First Received:	July 14, 2010
Last Updated:	December 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

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

Additional relevant MeSH terms:

Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013