Healthy
Conditions
Keywords
Naproxen Sodium, Bioavailability
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.
Interventions
DRUGNaproxen Sodium 660mg
Extended release Naproxen Sodium (660mg) administered once a day
DRUGCommercial Aleve 220 mg
Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters | Over 48 Hours |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety and tolerability of the investigational product | Over 48 Hours |
Countries
United States
Outcome results
None listed