Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Information source: Pozen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis
Intervention: PN400 (Drug); naproxen (Drug); naproxen (Drug)
Phase: Phase 1
Sponsored by: Pozen
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent
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
Study design: Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Primary outcome: To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
Secondary outcome: To evaluate the safety of the 3 treatments
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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
- Standard exclusion criteria for a study of this nature
Locations and Contacts
Austin, Texas, United States
Starting date: March 2008
Ending date: June 2008
Last updated: June 9, 2008