Single/Multiple Dose Bioavailability Trial
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Naproxen Sodium 660mgDrug: Commercial Aleve 220 mg
- Registration Number
- NCT00751556
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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)
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 Naproxen Sodium 660mg - Arm 2 Commercial Aleve 220 mg -
- Primary Outcome Measures
Name Time Method Pharmacokinetics parameters Over 48 Hours
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of the investigational product Over 48 Hours