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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992381
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : January 18, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: PN400 Drug: Naprosyn Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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)
Study Start Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: PN400
500mg Naproxen and 20mg esomeprazole
Other Name: VIMOVO™

Active Comparator: 2
Drug: Naprosyn
500mg Naproxen

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Compare the adverse event profile of PN 400 with that from Naprosyn® [ Time Frame: Adverse event reporting over 2 periods of 11 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992381

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

Responsible Party: MCMD, AstraZeneca Identifier: NCT00992381     History of Changes
Other Study ID Numbers: D1120C00035
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: January 2010

Keywords provided by AstraZeneca:
GI Pain
healthy participants

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