MedTrace Logo

Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study

NCT03167541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-02-28

Study results available
· View outcomes & findings →

Summary

This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands in order to support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).

Conditions

  • Healthy

Interventions

DRUG

Test

RB naproxen sodium tablets (2x220mg)

DRUG

Reference

Aleve naproxen sodium tablets (2x220mg)

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Robert Adams, MBBS · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-10-12
Primary Completion
2016-12-02
Completion
2016-12-02

More Related Trials

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 NCT03167541 on ClinicalTrials.gov