Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

Arthritis Clinical Trial

Official title:

An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665743
• Other study ID #: PN400-102
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2008
• Last updated: June 9, 2008
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: POZEN
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Standard exclusion criteria for a study of this nature

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• PN400
naproxen 500 mg /esomeprazole 20 mg
• naproxen
naproxen 500 mg tablet
• naproxen
naproxen 500 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
POZEN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations		72-hour PK	No
Secondary	To evaluate the safety of the 3 treatments		entire study duration	Yes