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

NCT01163630 | Completed Phase 1

• 1 other identifier: D961FC00009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Food; Pharmacokinetics

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• 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.

Study Arms (2)

1

EXPERIMENTAL

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

Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

2

EXPERIMENTAL

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

Drug: esomeprazole/ASA Fixed Dose Combination (FDC)

Interventions

esomeprazole/ASA Fixed Dose Combination (FDC) DRUG

esomeprazole 20 mg/ASA 81 mg oral capsule

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Oveland Park, Kansas, United States

Location

Study Officials

• Kelli Craven, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

• Ken Price

  AstraZeneca

  STUDY DIRECTOR

• Mirjana Kujacic

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

US (1)