An Open Label, Randomised 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 Under Fed Conditions.

NCT00818415 Phase 1 COMPLETED

To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2008-11
Completion	2008-11

Conditions

• Pain

Interventions

• Naproxen sodium ER (BAYH6689)
• Commercial Naproxen (Aleve, BAYH6689)

Primary outcomes

• Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions — 4 weeks

Countries

United States