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OpenTrials
Completed

NCT Number: NCT00803764

Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.

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Key information

Conditions

Bioequivalency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy men or women, non-smoker, 18 years of age or older
  • willing to participate and sign a copy of the informed consent form

Exclusion criteria

  • clinically significant illnesses or surgery within 4 weeks prior to study dosing
  • body mass index greater than or equal to 30.0
  • recent history of drug or alcohol addiction or abuse
  • pregnant or lactating women
  • history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
  • history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
  • history or known presence of gastrointestinal ulceration, bleeding and perforation
  • use of tobacco products within 6 months prior to study dosing
  • evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
  • receipt of any drugs as part of a research study within 30 days prior to study dosing

Treatment and study plan

Naproxen Tablets, 500 mg

Drug

Primary outcomes

  1. Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity

Sponsors and collaborators

Lead sponsor

Perrigo Company

Industry

Registry information

Official study title

Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions

Important dates

Study start
2004
Primary completion
2004
First posted
Dec 8, 2008
Registry last updated
Mar 16, 2012

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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