Single/Multiple Dose Bioavailability Trial

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00751556

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

33.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Naproxen Sodium 660mg Drug: Commercial Aleve 220 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label, Randomized, 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 in Healthy Adult Subjects

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Naproxen Sodium 660mg Extended release Naproxen Sodium (660mg) administered once a day
Active Comparator: Arm 2	Drug: Commercial Aleve 220 mg Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Naproxen Sodium 660mg

Extended release Naproxen Sodium (660mg) administered once a day

Active Comparator: Arm 2

Drug: Commercial Aleve 220 mg

Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total

Outcome Measures

Primary Outcome Measures

Pharmacokinetics parameters [Over 48 Hours]

Secondary Outcome Measures

Assess the safety and tolerability of the investigational product [Over 48 Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight >50 kg (110Ibs)

Exclusion Criteria:

History of hypersensitive 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 Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Little Rock	Arkansas	United States	72202

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00751556

Other Study ID Numbers:

13106

First Posted:

Sep 12, 2008

Last Update Posted:

Apr 21, 2014

Last Verified:

Apr 1, 2014

Keywords provided by Bayer

Naproxen Sodium

Bioavailability

Additional relevant MeSH terms:

Naproxen

Study Results

No Results Posted as of Apr 21, 2014