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

Sponsor:	AstraZeneca
Collaborator:	POZEN
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00992381

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:

Drug Information available for: Naproxen Naproxen sodium Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

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:

Naproxen
Omeprazole
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
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2012