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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163630
• Other study ID #: D961FC00009
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: December 6, 2010
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Effect of Food
• Pharmacokinetics

Intervention

Drug:
• esomeprazole/ASA Fixed Dose Combination (FDC)
esomeprazole 20 mg/ASA 81 mg oral capsule

Locations

Country	Name	City	State
United States	Research Site	Oveland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	To investigate PK of ASA and esomeprazole by assessment of tmax and t1/2?z 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	No
Secondary	To investigate the PK of ASA metabolite salicylic acid (SA) by assessment of AUC, AUC(0-t), Cmax, tmax and t1/2?z 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	No
Secondary	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	Yes
Secondary	To investigate the PK of ASA metabolite salicylic acid (SA) by assessment of AUC, AUC(0-t), Cmax, tmax and t1/2?z 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.	No