A Healthy Female and Male Volunteers Aspirin Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01448031
First received: September 22, 2011
Last updated: May 9, 2012
Last verified: May 2012
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Purpose
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Capsule ASA 81mg/esomeprazole 20mg Drug: Acetylsalicylzuur Apotex Cardio |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Phase I, Open-label, Randomized, Two Way Crossover Pharmacokinetic Study Comparing the Bioavailability of Acetylsalicylic Acid (ASA) After 5 Days Repeated Once Daily Administration of a Fixed Dose Combination Capsule of ASA 81 mg/Esomeprazole 20 mg and ASA 80 mg (European Aspirin Reference Product) |
Resource links provided by NLM:
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:
- pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2). [ Time Frame: Day 5 ] [ Designated as safety issue: No ]PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.
Secondary Outcome Measures:
- Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs [ Time Frame: Pre-dose up to 7 day after last dose ] [ Designated as safety issue: Yes ]No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis
| Enrollment: | 54 |
| Study Start Date: | November 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Capsule ASA 81mg/esomeprazole 20mg
|
Drug: Capsule ASA 81mg/esomeprazole 20mg
Multiple doses administered on Day 1 to 5
|
|
Active Comparator: 2
ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg
|
Drug: Acetylsalicylzuur Apotex Cardio
Multiple doses administered on Day 1 to 5
|
Detailed Description:
A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female subjects aged 20 to 50 years inclusive.
- Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
- Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
- History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448031
Locations
| United Kingdom | |
| Research Site | |
| London, UK, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Ronnie Beboso | BioKinetic Europe Ltd,14 Great Victoria Street,Belfast, N.Ireland,United Kingdom BT2 7BA |
| Study Director: | Tore Lind | AstraZeneca, Pepparedsleden 1 431 83 Molndal Sweden |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01448031 History of Changes |
| Other Study ID Numbers: | D961FC00012 |
| Study First Received: | September 22, 2011 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
Acetyl Salicylic Acid Bioavailability Healthy Volunteers |
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 22, 2013