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Single/Multiple Dose Bioavailability Trial

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ClinicalTrials.gov Identifier: NCT00751556
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Naproxen Sodium 660mg Drug: Commercial Aleve 220 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751556


Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00751556     History of Changes
Other Study ID Numbers: 13106
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by Bayer:
Naproxen Sodium
Bioavailability

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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