Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by:

POZEN

ClinicalTrials.gov Identifier:

NCT00632086

First received: February 29, 2008

Last updated: March 7, 2008

Last verified: February 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 29, 2008
Last Updated Date	March 7, 2008
Start Date ^ICMJE	February 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00632086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
Official Title ^ICMJE	A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Aspirin Administered as PA32540 (Aspirin/Omeprazole) or as the Aspirin Component of PA32540 or as Ecotrin® 325 mg in Healthy Volunteers
Brief Summary	Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: PA32540 Drug: aspirin component of PA32540 The 325 mg aspirin component of PA32540 Drug: Ecotrin 325 mg Ecotrin
Study Arm (s)	Experimental: 1 Single oral dose of 325 mg aspirin administered as PA32540 Intervention: Drug: PA32540 Experimental: 2 aspirin core Intervention: Drug: aspirin component of PA32540 Active Comparator: 3 active Intervention: Drug: Ecotrin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	36
Completion Date	February 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Standard for PK Ages 18-55 years old Males and females Exclusion Criteria: Standard for PK
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00632086
Other Study ID Numbers ^ICMJE	PA32540-104
Has Data Monitoring Committee	No
Responsible Party	Connie Powers, Pozen
Study Sponsor ^ICMJE	POZEN
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	POZEN
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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