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

NCT00751556 Phase 1 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2008-02
Completion	2008-03

Conditions

• Healthy

Interventions

• Naproxen Sodium 660mg
• Commercial Aleve 220 mg

Primary outcomes

• Pharmacokinetics parameters — Over 48 Hours

Countries

United States