Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

This study has been completed.

Sponsor:

Information provided by:

POZEN

ClinicalTrials.gov Identifier:

NCT00692055

First received: June 4, 2008

Last updated: September 4, 2008

Last verified: September 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 4, 2008
Last Updated Date	September 4, 2008
Start Date ^ICMJE	June 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 5, 2008)	To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations [ Time Frame: 72-hour PK ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00692055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 5, 2008)	To evaluate the safety of the two treatments [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Official Title ^ICMJE	Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Brief Summary	We will evaluate the bioavailability of naproxen 375 mg in two formulations
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Arthritis
Intervention ^ICMJE	Drug: PN400 naproxen 375 mg / esomeprazole 20 mg Drug: Naproxen naproxen 375 mg
Study Arm (s)	Experimental: 1 PN400 Intervention: Drug: PN400 Active Comparator: 2 naproxen 375 mg Intervention: Drug: Naproxen
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
Enrollment ^ICMJE	30
Completion Date	July 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy male or non-pregnant female subjects between 18-55 years as well as other standard inclusion criteria for a study of this nature Exclusion Criteria: Standard exclusion criteria for a study of this nature
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	United States

Administrative Information
NCT Number ^ICMJE	NCT00692055
Other Study ID Numbers ^ICMJE	PN400-105
Has Data Monitoring Committee	No
Responsible Party	David Taylor, POZEN
Study Sponsor ^ICMJE	POZEN
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	POZEN
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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