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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | esomeprazole 20mg/ASA 81 mg FDC after a 10-hour fast |
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| 2 | Experimental | esomeprazole 20mg/ASA 81 mg FDC 30 minutes after start of a high-fat, high-calorie breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole/ASA Fixed Dose Combination (FDC) | Drug | esomeprazole 20 mg/ASA 81 mg oral capsule |
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| Measure | Description | 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 | |
| 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Craven, MD | Quintiles, Inc. | Principal Investigator |
| Ken Price | AstraZeneca | Study Director |
| Mirjana Kujacic | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oveland Park | Kansas | United States |
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| 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. |