Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Information source: Pozen
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis
Intervention: PN400 (Drug); Naproxen (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pozen Overall contact:
David Taylor, Phone: 919-913-1030
Summary
We will evaluate the bioavailability of naproxen 375 mg in two formulations
Clinical Details
Official title: Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Study design: Basic Science, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Primary outcome: To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations
Secondary outcome: To evaluate the safety of the two treatments
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
David Taylor, Phone: 919-913-1030
Austin, Texas, United States
Additional Information
Starting date: June 2008
Ending date: July 2008
Last updated: June 5, 2008
|
