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Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan

NCT00969449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-05-20

No results posted yet for this study

Summary

To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions

Conditions

  • Pharmacokinetics

Interventions

DRUG

Naproxen Sodium, (BAY H6689)

One dose of Naproxen sodium extended release 660 mg under fasting conditions

DRUG

Naprelan, (BAY H6689)

One dose of Naprelan 500 mg (2 tablets) under fasting conditions

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
2009-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT00969449 on ClinicalTrials.gov