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Completed

NCT Number: NCT00907400

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

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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, Luleå, Sweden

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
  • Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
  • Clinically normal physical exams and laboratory measurements

Exclusion criteria

  • Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
  • Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
  • Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
  • Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

Treatment and study plan

PN400

Drug

oral tablet

Other names: VIMOVO™

Naproxen

Drug

oral tablet

Other names: Naprosyn E

Primary outcomes

  1. Pharmacokinetics

    Time frame: pre-dose and multiple times post-dose

Secondary outcomes

  1. Safety

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 22, 2009
Registry last updated
Dec 10, 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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