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

Exclusion Criteria

• •History of hypersensitivity to aspirin (ASA), naproxen sodium, NSAIDs, acetaminophen, DPH HCL, and similar pharmacological agents or components of the products
• •History of hypersensitivity to any of the food products in the standardized breakfast or cannot consume all food/beverage items contained in the standardized breakfast
• •Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) 7 days prior to dosing or during the Dosing Periods, other than trial treatment
• •Use of any over-the-counter or prescription medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
• •Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or 1-2 weeks after treatment
• •Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
• •History of gastrointestinal bleeding or perforation, related to previous NSAID therapy or active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
• •Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
• •Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial