Single/Multiple Dose Bioavailability Trial
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Naproxen Sodium 660mg
Drug: Commercial Aleve 220 mg
Details and patient eligibility
About
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.
Enrollment
32 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
32 participants in 2 patient groups
Arm 1
Experimental group
Treatment:
Drug: Naproxen Sodium 660mg
Arm 2
Active Comparator group
Treatment:
Drug: Commercial Aleve 220 mg
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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