Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00692055
First received: June 4, 2008
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

We will evaluate the bioavailability of naproxen 375 mg in two formulations


Condition Intervention Phase
Arthritis
Drug: PN400
Drug: Naproxen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations [ Time Frame: 72-hour PK ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of the two treatments [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PN400
Drug: PN400
naproxen 375 mg / esomeprazole 20 mg
Active Comparator: 2
naproxen 375 mg
Drug: Naproxen
naproxen 375 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692055

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
POZEN
  More Information

No publications provided

Responsible Party: David Taylor, POZEN
ClinicalTrials.gov Identifier: NCT00692055     History of Changes
Other Study ID Numbers: PN400-105
Study First Received: June 4, 2008
Last Updated: September 4, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014