Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 29, 2012

Study Completion Date

March 31, 2012

Conditions
Therapeutic Equivalence
Interventions
DRUG

BAY98-7111

2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions

DRUG

Naproxen Sodium (Aleve, BAYH6689)

2 x Naproxen Sodium 220 mg under fasting conditions

DRUG

Diphenhydramine HCl

2 x Diphenhydramine HCl 25 mg under fasting conditions

DRUG

BAY98-7111

2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions

Trial Locations (1)

07601

Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY