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Naproxen Sodium ER Pharmacokinetic Study

NCT00818415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-05-19

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Naproxen sodium ER (BAYH6689)

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

DRUG

Commercial Naproxen (Aleve, BAYH6689)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818415 on ClinicalTrials.gov