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OpenTrials
Completed

NCT Number: NCT00992381

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PN400

Drug

500mg Naproxen and 20mg esomeprazole

Other names: VIMOVO™

Naprosyn

Drug

500mg Naproxen

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • POZEN

Registry information

Official study 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)

Important dates

Study start
2009
Study completion
2009
First posted
Oct 9, 2009
Registry last updated
Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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