Study Evaluating the Effect of Food on the Bioavailability of PN400 Components - Full Text View

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00676442

Purpose

We will evaluate the effect of food on the bioavailability of the components of PN400

Condition	Intervention	Phase
Arthritis	Drug: PN400	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-availability Study
Official Title:	An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects

Further study details as provided by Pozen:

Primary Outcome Measures:

To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects. [ Time Frame: 72-hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of PN 400 under fasting and fed conditions. [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	May 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 PN400 administered after meal	Drug: PN400 naproxen/esomeprazole
2 PN400 administered prior to meal	Drug: PN400 naproxen/esomeprazole
3 PN400 administered prior to meal	Drug: PN400 naproxen/esomeprazole
4 PN400 followed by fast	Drug: PN400 naproxen/esomeprazole

Eligibility

Criteria

Inclusion Criteria:

Healthy male or non-pregnant female subjects between 18-55 years old as well as other standard inclusion criteria for a study of this nature.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676442

Locations

Sponsors and Collaborators

Pozen

More Information

Responsible Party:	Pozen ( Director, Clinical Research )
Study ID Numbers:	PN400-103
Study First Received:	May 8, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00676442
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Naproxen
Musculoskeletal Diseases
Guaifenesin
Phenylephrine

Joint Diseases
Arthritis
Omeprazole
Phenylpropanolamine
Healthy

ClinicalTrials.gov processed this record on January 14, 2009