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Single/Multiple Dose Bioavailability Trial

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 11, 2008
Last updated: April 18, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Drug: Naproxen Sodium 660mg
Drug: Commercial Aleve 220 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics parameters [ Time Frame: Over 48 Hours ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of the investigational product [ Time Frame: Over 48 Hours ]

Enrollment: 32
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Naproxen Sodium 660mg
Extended release Naproxen Sodium (660mg) administered once a day
Active Comparator: Arm 2 Drug: Commercial Aleve 220 mg
Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00751556

United States, Arkansas
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00751556     History of Changes
Other Study ID Numbers: 13106
Study First Received: September 11, 2008
Last Updated: April 18, 2014

Keywords provided by Bayer:
Naproxen Sodium

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on March 29, 2017