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Trial: NCT00998075 [RDF]

Label NCT00998075
Slug nct00998075
Trialid NCT00998075
Lookup name NCT00998075
Provenance http://clinicaltrials.gov/show/NCT00998075?displayxml=true
Lastchanged date December 6, 2010
Firstreceived results date
Firstreceived date October 19, 2009
Id info nct id NCT00998075
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 138
Number of arms 3
Is section 801
Is fda regulated No
Brief title Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
Acronym
Official title A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet
Study type Interventional
Id info nct alias
Completion date December 2009
Verification date December 2010
Why stopped
Id info org study id D961FC00007
Required header url https://clinicaltrials.gov/show/NCT00998075
Study design Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Source AstraZeneca
Primary completion date December 2009
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 07, 2016
Phase Phase 1
Start date September 2009
Has expanded access No
Biospec descr
Detailed description
Condition browse e9f0ec8b5db9075af18a3fc91a640128
Intervention browse 123afa0a3053f13142035337f2efd63a
Responsible party 816be7a455f659b2cff8c2452ad6eda3
Overall contact None
Overall contact backup None
Sponsor group 0fce9358a4130bad9ccae5178ff23345
Oversight info Canada: Health Canada (Oversight_info)
Eligibility 767b14117f56374199122f3fbe4f2be9
Keywords ASA, Bioequivalence, Esomeprazole, healthy volunteers, peptic ulcer disease, primary cardiovascular protection
Conditions Peptic Ulcer Disease
Locations c206416cabb3e0912d2226ab1e38d908
Links None
Results references None
Arm groups 2 (Arm Group), 3 (Arm Group), 1 (Arm Group)
Location countries Canada
Interventions Esomeprazole - Nexium (Intervention), ASA (Intervention), Esomeprazole/ASA Fixed Combination (Intervention)
Secondary outcomes 6f8ea7102bc8dacb1fbf6a4b595c2201
References None
Primary outcomes a84f68a5708a65a284807f1478fc56b3
Removed countries None
Overall officials 299214bf8d3dd29587b2bcf0da8160f4, 52d596b071ba03727cfc17e63881f25a