Naproxen Sodium ER Pharmacokinetic Study

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Naproxen sodium ER (BAYH6689); Drug: Commercial Naproxen (Aleve, BAYH6689)

• Registration Number: NCT00818415
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Naproxen sodium ER (BAYH6689)	-
Arm 2	Commercial Naproxen (Aleve, BAYH6689)	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions	4 weeks

Secondary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of an extended release tablet of Naproxen Sodium	4 weeks