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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01666678
First received: August 14, 2012
Last updated: August 8, 2013
Last verified: August 2013

August 14, 2012
August 8, 2013
January 2012
February 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01666678 on ClinicalTrials.gov Archive Site
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Therapeutic Equivalence
  • 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
  • Experimental: Arm 1
    Intervention: Drug: BAY98-7111
  • Active Comparator: Arm 2
    Intervention: Drug: Naproxen Sodium (Aleve, BAYH6689)
  • Active Comparator: Arm 3
    Intervention: Drug: Diphenhydramine HCl
  • Experimental: Arm 4
    Intervention: Drug: BAY98-7111
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01666678
16135
No
Head Clinical and Medical Affairs, Bayer Consumer Care L.L.C.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP