Naproxen Sodium ER Pharmacokinetic Study

NCT00818415 | Completed Phase 1

• 1 other identifier: 13965
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions

  4 weeks

Secondary Outcomes (1)

• Assess the safety and tolerability of an extended release tablet of Naproxen Sodium

  4 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Naproxen sodium ER (BAYH6689)

Arm 2

ACTIVE COMPARATOR

Drug: Commercial Naproxen (Aleve, BAYH6689)

Interventions

Naproxen sodium ER (BAYH6689) DRUG

Extented release Naproxen sodium (660mg) administered once a day

Arm 1

Commercial Naproxen (Aleve, BAYH6689) DRUG

Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily

Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: January 7, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

US (1)