Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone

This study has been completed.
Sponsor:
Collaborator:
POZEN
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00992381
First received: October 8, 2009
Last updated: January 15, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.


Condition Intervention Phase
Healthy
Drug: PN400
Drug: Naprosyn
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet [ Time Frame: blood samples taken at various time points over 2 treatment periods of 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet, [ Time Frame: Blood samples taken at various time point over 2 periods of 2 days ] [ Designated as safety issue: No ]
  • Compare the adverse event profile of PN 400 with that from Naprosyn® [ Time Frame: Adverse event reporting over 2 periods of 11 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1
PN400
Drug: PN400
500mg Naproxen and 20mg esomeprazole
Other Name: VIMOVO™
Active Comparator: 2
Naproxen
Drug: Naprosyn
500mg Naproxen
Other Name: Naprosyn

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive).
  • Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results
  • Subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent

Exclusion Criteria:

  • Significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration.
  • Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first Period 1 dose
  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: NCT00992381

Locations
Australia, Queensland
Research Site
Brisbane, Queensland, Australia
Sponsors and Collaborators
AstraZeneca
POZEN
Investigators
Study Director: Terry Hurst Q-Pharm Phase one unit
Principal Investigator: Jo Marjason Q-Pharm Phase one unit
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00992381     History of Changes
Other Study ID Numbers: D1120C00035
Study First Received: October 8, 2009
Last Updated: January 15, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:
GI Pain
healthy participants
Safety
bioavailability

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

ClinicalTrials.gov processed this record on October 22, 2014