Single/Multiple Dose Bioavailability Trial - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00751556

Purpose

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
Healthy	Drug: Naproxen Sodium 660mg Drug: Commercial Aleve 220 mg	Phase I

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Pharmacokinetics parameters [ Time Frame: Over 48 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability of the investigational product [ Time Frame: Over 48 Hours ] [ Designated as safety issue: Yes ]

Enrollment:	55
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
Arm 1: Experimental	Drug: Naproxen Sodium 660mg Extended release Naproxen Sodium (660mg) administered once a day
Arm 2: Active Comparator	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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751556

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Consumer Care Inc. ( Head Clinical Pharmacology )
Study ID Numbers:	13106
Study First Received:	September 11, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00751556 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Naproxen Sodium
Bioavailability

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Healthy
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009