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

• ClinicalTrials.gov Identifier: NCT01666678
• Recruitment Status: Completed
• First Posted: August 16, 2012
• Last Update Posted: August 21, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.

Condition or disease	Intervention/treatment	Phase
Therapeutic Equivalence	Drug: BAY98-7111; Drug: Naproxen Sodium (Aleve, BAYH6689); Drug: Diphenhydramine HCl	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions
• Study Start Date: January 2012
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Drug: BAY98-7111; 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
Active Comparator: Arm 2	Drug: Naproxen Sodium (Aleve, BAYH6689); 2 x Naproxen Sodium 220 mg under fasting conditions
Active Comparator: Arm 3	Drug: Diphenhydramine HCl; 2 x Diphenhydramine HCl 25 mg under fasting conditions
Experimental: Arm 4	Drug: BAY98-7111; 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions

Outcome Measures

Primary Outcome Measures :

1. AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium [ Time Frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing ]
2. AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride) [ Time Frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing ]
3. Cmax(Maximum drug concentration) in plasma of naproxen sodium [ Time Frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing ]
4. Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride) [ Time Frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing ]

Secondary Outcome Measures :

1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Health, ambulatory male and female subjects between 18 to 55 years of age inclusive
• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs)
• Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

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

Contacts and Locations

Locations

United States, New Jersey

Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01666678
• Other Study ID Numbers: 16135
• First Posted: August 16, 2012
• Last Update Posted: August 21, 2014
• Last Verified: August 2014

Keywords provided by Bayer:

Bioequivalence

Additional relevant MeSH terms:

Diphenhydramine; Promethazine; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Sleep Aids, Pharmaceutical; Hypnotics and Sedatives; Central Nervous System Depressants; Anesthetics, Local; Anesthetics; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Allergic Agents; Antipruritics; Dermatologic Agents