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OpenTrials
Completed

NCT Number: NCT00751556

Single/Multiple Dose Bioavailability Trial

To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.

Completed

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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

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight >50 kg (110Ibs)

Exclusion criteria

  • History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
  • History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
  • Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment

Treatment and study plan

Naproxen Sodium 660mg

Drug

Extended release Naproxen Sodium (660mg) administered once a day

Commercial Aleve 220 mg

Drug

Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total

Primary outcomes

  1. Pharmacokinetics parameters

    Time frame: Over 48 Hours

Secondary outcomes

  1. Assess the safety and tolerability of the investigational product

    Time frame: Over 48 Hours

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2008
Registry last updated
Apr 21, 2014

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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