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Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily

NCT02549469 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-09-15

No results posted yet for this study

Summary

Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.

Conditions

Interventions

DRUG

Naproxen Sodium ER (BAY117031), 20% HPMC

1 tablet 660 mg administered orally once daily

DRUG

Naproxen Sodium ER (BAY117031), 30% HPMC

1 tablet 660 mg administered orally once daily

DRUG

Naproxen Sodium ER (BAY117031), 40% HPMC

1 tablet 660 mg administered orally once daily

DRUG

Aleve (Naproxen Sodium, BAY117031)

1 tablet 220 mg administered orally three times 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
2007-03-31
Primary Completion
2007-05-31
Completion
2007-05-31

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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 NCT02549469 on ClinicalTrials.gov