Naproxen Sodium ER Pharmacokinetic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00818415
First received: December 8, 2008
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Pain
Drug: Naproxen sodium ER (BAYH6689)
Drug: Commercial Naproxen (Aleve, BAYH6689)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of an extended release tablet of Naproxen Sodium [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Naproxen sodium ER (BAYH6689)
Extented release Naproxen sodium (660mg) administered once a day
Active Comparator: Arm 2 Drug: Commercial Naproxen (Aleve, BAYH6689)
Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/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 and the 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, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of 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
  • Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
  • Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion Criteria:

  • History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
  • History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. 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
  • Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
  • 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
  • Alcoholism or drug abuse within 2 years prior to the Screening Visit
  • Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818415

Locations
United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00818415     History of Changes
Other Study ID Numbers: 13965
Study First Received: December 8, 2008
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014