NCT00665743CompletedPhase 1
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
POZEN0 sites30 target enrollmentStarted: March 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
Study Overview
Brief Summary
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A
Experimental
PN400 (naproxen/esomeprazole)
Intervention: PN400 (Drug)
C
Active Comparator
naproxen 500 mg
Intervention: naproxen (Drug)
B
Active Comparator
naproxen 500 mg
Intervention: naproxen (Drug)
Outcomes
Primary Outcomes
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
Time Frame: 72-hour PK
Secondary Outcomes
- To evaluate the safety of the 3 treatments(entire study duration)
Investigators
Similar Trials
Completed
Phase 1
Study Evaluating the Bioavailability of Naproxen 375 mg in Two FormulationsArthritisNCT00692055POZEN30
Completed
Phase 1
Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mgChagas DiseaseNCT03350295Bayer48
Completed
Phase 1
A Relative Bioavailability Study of Two Formulations of BCX7353Hereditary AngioedemaNCT03202784BioCryst Pharmaceuticals24
Completed
Phase 1
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference FormulationEstrogen Replacement TherapyNCT00401219Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen FormulationHealthy VolunteersBioequivalenceNCT01331993AstraZeneca36