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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01163630
First received: July 14, 2010
Last updated: December 6, 2010
Last verified: December 2010

July 14, 2010
December 6, 2010
June 2010
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01163630 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Effect of Food
  • Pharmacokinetics
Drug: esomeprazole/ASA Fixed Dose Combination (FDC)
esomeprazole 20 mg/ASA 81 mg oral capsule
  • Experimental: 1
    esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast
    Intervention: Drug: esomeprazole/ASA Fixed Dose Combination (FDC)
  • Experimental: 2
    esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast
    Intervention: Drug: esomeprazole/ASA Fixed Dose Combination (FDC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01163630
D961FC00009
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Kelli Craven, MD Quintiles
Study Director: Ken Price AstraZeneca
Study Director: Mirjana Kujacic AstraZeneca
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP